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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02924727




Registration number
NCT02924727
Ethics application status
Date submitted
4/10/2016
Date registered
5/10/2016

Titles & IDs
Public title
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
Scientific title
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an Acute Myocardial Infarction (AMI)
Secondary ID [1] 0 0
2016-002154-20
Secondary ID [2] 0 0
CLCZ696G2301
Universal Trial Number (UTN)
Trial acronym
PARADISE-MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LCZ696 (sacubitril/valsartan)
Treatment: Drugs - Ramipril
Treatment: Drugs - Placebo of LCZ696
Treatment: Drugs - Placebo of ramipril
Treatment: Drugs - Valsartan
Treatment: Drugs - Placebo of valsartan

Experimental: LCZ696 (sacubitril/valsartan) - Following randomization, patients will receive LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily).

Patients will be required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from ramipril matching placebo pack) twice a day for the duration of the study.

Patients randomized to LCZ who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will receive a valsartan bridge for one day. These patients will receive two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.

Active comparator: Ramipril - Following randomization, patients will receive the Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily).

Patients will be required to take a total of two pills, (one capsule from the ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study.

Patients randomized to ramipril who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will immediately start on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients will receive two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.


Treatment: Drugs: LCZ696 (sacubitril/valsartan)
LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively

Treatment: Drugs: Ramipril
Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules

Treatment: Drugs: Placebo of LCZ696
Matching placebo of LCZ696 tablets

Treatment: Drugs: Placebo of ramipril
Matching placebo of ramipril capsule

Treatment: Drugs: Valsartan
Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day to patients who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization

Treatment: Drugs: Placebo of valsartan
matching placebo of valsartan for one day to patients who will be randomized to received ramipril
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint
Timepoint [1] 0 0
From randomization to first occurrence (up to approximately 43 months)
Secondary outcome [1] 0 0
Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization
Timepoint [1] 0 0
Time from randomization to first occurrence (up to approximately 43 months)
Secondary outcome [2] 0 0
Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF
Timepoint [2] 0 0
Time from randomization to first occurrence (approximately up to 43 months)
Secondary outcome [3] 0 0
Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke
Timepoint [3] 0 0
Time from randomization to first occurrence (approximately up to 43 months)
Secondary outcome [4] 0 0
Total Number of Confirmed Composite Endpoints
Timepoint [4] 0 0
Time from randomization to end of study (approximately up to 43 months)
Secondary outcome [5] 0 0
All-cause Mortality for Full Analysis Set (FAS)
Timepoint [5] 0 0
Time from randomization to death (approximately up to 43 months)

Eligibility
Key inclusion criteria
1. Male or female patients = 18 years of age.
2. Diagnosis of spontaneous AMI based on the universal MI definition* with randomization to occur between 12 hours and 7 days after index event presentation. (*patients with spontaneous MI event determined to be secondary to another medical condition such as anemia, hypotension, or arrhythmia OR thought to be caused by coronary vasospasm with document normal coronary arteries are not eligible; patients with clinical presentation thought to be related to Takotsubo cardiomyopathy are also not eligible)
3. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as:

* LVEF =40% after index MI presentation and prior to randomization and/or
* Pulmonary congestion requiring intravenous treatment with diuretics, vasodilators, vasopressors and/or inotropes, during the index hospitalization
4. At least one of the following 8 risk factors:

* Age = 70 years
* eGFR <60 mL/min/1.73 m^2 based on MDRD formula at screening visit
* Type I or II diabetes mellitus
* Documented history of prior MI
* Atrial fibrillation as noted by ECG, associated with index MI
* LVEF <30% associated with index MI
* Worst Killip class III or IV associated with index MI requiring intravenous treatment
* STEMI without reperfusion therapy within the first 24 hours after presentation
5. Hemodynamically stable defined as:

* SBP = 100 mmHg at randomization for patients who received ACEi/ARB during the last 24 hours prior to randomization
* SBP = 110 mmHg at randomization for patients who did not receive ACEi/ARB during the last 24 hours prior to randomization
* No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known history of chronic HF prior to randomization
2. Cardiogenic shock within the last 24 hours prior to randomization
3. Persistent clinical HF at the time of randomization
4. Coronary artery bypass graft (CABG) performed or planned for index MI
5. Clinically significant right ventricular MI as index MI
6. Symptomatic hypotension at screening or randomization
7. Patients with a known history of angioedema
8. Stroke or transient ischemic attack within one month prior to randomization
9. Known or suspected bilateral renal artery stenosis
10. Clinically significant obstructive cardiomyopathy
11. Open-heart surgery performed within one month prior to randomization or planned cardiac surgery w/in the 3 months prior to randomization
12. eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
13. Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at randomization
14. Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
15. Previous use of LCZ696
16. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 3 years with a life expectancy of less than 1year.
17. History of hypersensitivity to the study drugs or drugs of similar chemical classes or known intolerance or contraindications to study drugs or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
18. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

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 administering 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/02/2021
Sample size
Target
Accrual to date
Final
5669
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Chemside
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Novartis Investigative Site - Herston
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Novartis Investigative Site - Bedford Park
Recruitment hospital [4] 0 0
Novartis Investigative Site - Hobart
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Novartis Investigative Site - Geelong
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Novartis Investigative Site - Murdoch
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4032 - Chemside
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4029 - Herston
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5041 - Bedford Park
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7000 - Hobart
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3220 - Geelong
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02924727