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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06008756




Registration number
NCT06008756
Ethics application status
Date submitted
17/08/2023
Date registered
24/08/2023
Date last updated
21/06/2024

Titles & IDs
Public title
MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
Scientific title
Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
Secondary ID [1] 0 0
jRCT2071230064
Secondary ID [2] 0 0
0616-015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arteriosclerosis 0 0
Hypercholesterolaemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MK-0616
Treatment: Drugs - Placebo

Experimental: MK-0616 - Participants receive MK-0616 20 mg once daily.

Placebo comparator: Placebo - Participants receive placebo once daily.


Treatment: Drugs: MK-0616
MK-0616 20 mg tablet taken by mouth.

Treatment: Drugs: Placebo
Placebo tablet matched to MK-0616 taken by mouth.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus
Timepoint [1] 0 0
From date of randomization until the date of first occurrence of CHD death-based MACE-plus, assessed up to approximately 6 years
Secondary outcome [1] 0 0
Time to First Occurrence of 3-point MACE
Timepoint [1] 0 0
From date of randomization until the date of first occurrence of 3-point MACE, assessed up to approximately 6 years
Secondary outcome [2] 0 0
Time to First Occurrence of Cardiovascular (CV) Death-Based MACE Plus
Timepoint [2] 0 0
From date of randomization until the date of first occurrence of CV death-based MACE plus, assessed up to approximately 6 years
Secondary outcome [3] 0 0
Time to First Occurrence of CHD Death or MI
Timepoint [3] 0 0
From date of randomization until the date of first occurrence of CHD death or MI, assessed up to approximately 6 years
Secondary outcome [4] 0 0
Time to CV Death
Timepoint [4] 0 0
From date of randomization until the date of CV death, assessed up to approximately 6 years
Secondary outcome [5] 0 0
Time to All-Cause Death
Timepoint [5] 0 0
From date of randomization until the date of death, assessed up to approximately 6 years
Secondary outcome [6] 0 0
Time to CHD Death
Timepoint [6] 0 0
From date of randomization until the date of CHD death, assessed up to approximately 6 years
Secondary outcome [7] 0 0
Time to First Event of MI
Timepoint [7] 0 0
From date of randomization until the date of MI, assessed up to approximately 6 years
Secondary outcome [8] 0 0
Time to First Event of Ischemic Stroke
Timepoint [8] 0 0
From date of randomization until the date of first occurrence of ischemic stroke, assessed up to approximately 6 years
Secondary outcome [9] 0 0
Time to First Event of Acute Limb Ischemia or Major Amputation
Timepoint [9] 0 0
From date of randomization until the date of first occurrence of acute limb ischemia or major amputation, assessed up to approximately 6 years
Secondary outcome [10] 0 0
Time to First Event of Urgent Arterial Revascularization
Timepoint [10] 0 0
From date of randomization until the date of urgent arterial revascularization, assessed up to approximately 6 years
Secondary outcome [11] 0 0
Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Timepoint [11] 0 0
Baseline and Week 52
Secondary outcome [12] 0 0
Percent Change from Baseline in Apolipoprotein B
Timepoint [12] 0 0
Baseline and Week 52
Secondary outcome [13] 0 0
Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) cholesterol
Timepoint [13] 0 0
Baseline and Week 52
Secondary outcome [14] 0 0
Percent Change from Baseline in Lipoprotein (a)
Timepoint [14] 0 0
Baseline and Week 52
Secondary outcome [15] 0 0
Number of Participants with an Adverse Event (AE)
Timepoint [15] 0 0
Up to ~6 years
Secondary outcome [16] 0 0
Number of Participants Discontinuing from Study Therapy Due to AE
Timepoint [16] 0 0
Up to ~6 years

Eligibility
Key inclusion criteria
* Meets one of the following:

1. Age =18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: =30 days post MI (presumed Type 1 due to plaque rupture or erosion); =30 days post ischemic stroke (presumed due to atherosclerosis); or =30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis; or
2. High risk for first major ASCVD event defined as at least 1 of the following: Age =50 years with evidence of coronary artery disease; Age =50 years with evidence of atherosclerotic cerebrovascular disease; Age =50 years with evidence of peripheral arterial disease; or Age =60 years with diabetes mellitus and at least one of the following: microvascular disease or urine albumin-creatinine ratio =30 mg/mmol within 6 months before Visit 1, daily insulin use, or diabetes for =10 years
* Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows:

1. History of major ASCVD Event: LDL-C =70 mg/dL (1.81 mmol/L) OR non-HDL-C =100 mg/dL (2.59 mmol/L)
2. High risk for first major ASCVD Event: LDL-C =90 mg/dL (2.33 mmol/L) OR non-HDL-C =120 mg/dL (3.11 mmol/L)
* Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy [LLT]) at Visit 1
* Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
* Has New York Heart Association Class IV heart failure, last known Left Ventricular Ejection Fraction =25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening)
* Has recurrent ventricular tachycardia within 3 months prior to randomization
* Has a planned arterial revascularization procedure
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
* Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout.
* Has a fasting triglyceride value =400 mg/dL (=4.52 mmol/L) at Visit 1 (Screening)
* Has history of severe renal insufficiency defined as estimated glomerular filtration rate <30 mL/min/1.73 m2 at Visit 1 (Screening) or has end-stage renal disease on dialysis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/11/2029
Actual
Sample size
Target
14550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra ( Site 2804) - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney ( Site 2805) - Blacktown
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital ( Site 2808) - Camperdown
Recruitment hospital [4] 0 0
Paratus Clinical Research Central Coast ( Site 2806) - Kanwal
Recruitment hospital [5] 0 0
Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803) - Clayton
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2259 - Kanwal
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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District of Columbia
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United States of America
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Cordoba
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Santa Fe
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Ceara
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Goias
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Parana
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Rio Grande Do Sul
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Sergipe
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Araucania
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Maule
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Chile
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Valparaiso
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Guangdong
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Guizhou
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China
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Hainan
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China
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Heilongjiang
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China
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Henan
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Hubei
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Hunan
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Inner Mongolia
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Jiangxi
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Jilin
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Liaoning
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Ningxia
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China
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China
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Tianjin
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China
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Zhejiang
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Caldas
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Colombia
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Cesar
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Colombia
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Cordoba
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Colombia
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Cundinamarca
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Colombia
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Santander
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Colombia
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Tolima
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Colombia
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Valle Del Cauca
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Denmark
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Nordjylland
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Denmark
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Sjaelland
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Denmark
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Syddanmark
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Hong Kong
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Hksar
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Hong Kong
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Pok Fu Lam
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Hong Kong
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Shatin
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Hungary
State/province [93] 0 0
Hajdu-Bihar
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Hungary
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Szabolcs-Szatmar-Bereg
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Hungary
State/province [95] 0 0
Budapest
Country [96] 0 0
Hungary
State/province [96] 0 0
Debrecen
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Hungary
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Zalaegerszeg
Country [98] 0 0
Israel
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Ashkelon
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Israel
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Be'er Sheva
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Herzliya
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Sakhnin
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Japan
State/province [108] 0 0
Aichi
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Japan
State/province [109] 0 0
Chiba
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Nagasaki
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Japan
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Saga
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Kumamoto
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Japan
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Okayama
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Japan
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Osaka
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Taegu-Kwangyokshi
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Tamaulipas
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Mexico
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Yucatan
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Mexico
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Veracruz
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Netherlands
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Aruba
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Netherlands
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Drenthe
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Netherlands
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Fryslan
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Netherlands
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Gelderland
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Netherlands
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Limburg
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Utrecht
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Netherlands
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Zeeland
Country [143] 0 0
Netherlands
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Zuid-Holland
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New Zealand
State/province [144] 0 0
Bay Of Plenty
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New Zealand
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Canterbury
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New Zealand
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Manawatu-Wanganui
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New Zealand
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Waikato
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New Zealand
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Wellington
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New Zealand
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Auckland
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New Zealand
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Nelson
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Norway
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Akershus
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Norway
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Hordaland
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Norway
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Nordland
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Norway
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Oslo
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Peru
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Ariqipa
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Peru
State/province [156] 0 0
La Libertad
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Peru
State/province [157] 0 0
Muni Metro De Lima
Country [158] 0 0
Peru
State/province [158] 0 0
Lima
Country [159] 0 0
Peru
State/province [159] 0 0
Piura
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South Africa
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Eastern Cape
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Western Cape
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Spain
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Andalucia
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Spain
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Cataluna
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Spain
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La Coruna
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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Spain
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Murcia, Region De
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Spain
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Sevilla
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei
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Taiwan
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Tainan
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Taiwan
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Taichung
Country [176] 0 0
Taiwan
State/province [176] 0 0
Taipei
Country [177] 0 0
Turkey
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Ankara
Country [178] 0 0
Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
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Antalya
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Turkey
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Edirne
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Turkey
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Eskisehir
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Turkey
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Kocaeli
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Turkey
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Konya
Country [185] 0 0
United Kingdom
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Bristol, City Of
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Devon
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United Kingdom
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England
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United Kingdom
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Glasgow City
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United Kingdom
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Northamptonshire
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Sheffield
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Walsall

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.
Trial website
https://clinicaltrials.gov/study/NCT06008756
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Toll Free Number
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1-888-577-8839
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Trialsites@merck.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06008756