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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03048825




Registration number
NCT03048825
Ethics application status
Date submitted
3/02/2017
Date registered
9/02/2017

Titles & IDs
Public title
Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry
Scientific title
A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients with Myocardial Infarction / SYNERGY Stent Registry - Organization to Assess Strategies for Ischemic Syndromes 9
Secondary ID [1] 0 0
OASIS-9
Secondary ID [2] 0 0
CLSYN.1702
Universal Trial Number (UTN)
Trial acronym
CLEAR SYNERGY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST Elevation Myocardial Infarction 0 0
Non ST Elevation 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 - Colchicine
Treatment: Drugs - Spironolactone
Treatment: Devices - SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
Treatment: Drugs - Colchicine-Placebo
Treatment: Drugs - Spironolactone-Placebo

Active comparator: Colchicine + Spironolactone +/- SYNERGY Stent - Colchicine 0.5 mg tablet + Spironolactone 25 mg tablet.

Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.

Active comparator: Spironolactone +/- SYNERGY Stent - Colchicine-placebo tablet + Spironolactone 25 mg tablet.

Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.

Active comparator: Colchicine +/- SYNERGY Stent - Colchicine 0.5 mg tablet + Spironolactone-placebo tablet.

Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.

Placebo comparator: Placebo +/- SYNERGY Stent - Colchicine-placebo tablet + Spironolactone-placebo tablet.

Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.


Treatment: Drugs: Colchicine
Colchicine 0.5 mg once daily

Treatment: Drugs: Spironolactone
Spironolactone 25 mg once daily

Treatment: Devices: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
Trial participants who receive a SYNERGY™ Bioabsorbable Polymer Drug-Eluting (everolimus) Stent during their index PCI for STEMI will be included in the SYNERGY Stent Registry.

Treatment: Drugs: Colchicine-Placebo
Matching Colchicine-placebo once daily

Treatment: Drugs: Spironolactone-Placebo
Matching Spironolactone-Placebo once daily
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Cardiac Events (MACE)
Timepoint [1] 0 0
up to 1 year
Primary outcome [2] 0 0
Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization
Timepoint [2] 0 0
through study completion, an estimated average of 3 years
Primary outcome [3] 0 0
Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)
Timepoint [3] 0 0
through study completion, an estimated average of 3 years
Primary outcome [4] 0 0
Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2)
Timepoint [4] 0 0
through study completion, an estimated average of 3 years

Eligibility
Key inclusion criteria
1. a) Patients with STEMI referred for PCI within 12 hours of symptom onset, have a culprit lesion amenable to stenting, and with planned SYNERGY stent implantation for SYNERGY registry

OR

b) Patients with STEMI referred for PCI within 48 hours of symptom onset, not prospectively enrolled in SYNERGY stent registry

OR

c) Patients with diagnosis of Non STEMI with ischemic symptoms and either Hs Troponin > or = 300x ULN or Troponin > or = 200x ULN who have undergone PCI with one of the following:

i. LVEF< or =45% ii. Diabetes iii. Multivessel CAD defined as 50% stenosis in 2nd major epicardial vessel iv. Prior MI v. Age >60 years
2. Able to be enrolled/randomized within 72 hours of index PCI (however patients should be randomized as soon as possible after PCI)
3. Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age =18 years
2. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
3. Any medical, geographic, or social factor making study participation impractical or precluding required follow-up
4. Systolic blood pressure <90 mm Hg
5. Active diarrhea
6. Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components
7. Unable to receive dual antiplatelet therapy
8. Any contraindication or known intolerance to colchicine or spironolactone
9. Requirement for colchicine or mineralocorticoid antagonist for another indication
10. History of cirrhosis or current severe hepatic disease
11. Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics
12. Creatinine clearance <30 mL/min/1.73 m2
13. Serum Potassium >5.0 meq/L

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
Factorial
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
1/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2024
Sample size
Target
Accrual to date
Final
7264
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Bankstown-Lidcombe hospital - Bankstown
Recruitment hospital [2] 0 0
SWSLHD - Campbelltown - Campbelltown
Recruitment hospital [3] 0 0
SWSLHD - Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Peninsula Health - Frankston
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Rhode Island
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Canada
State/province [15] 0 0
Saskatchewan
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Karlovy Vary
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague
Country [19] 0 0
Egypt
State/province [19] 0 0
Dakahlia
Country [20] 0 0
Egypt
State/province [20] 0 0
Kharga
Country [21] 0 0
Egypt
State/province [21] 0 0
Alexandria
Country [22] 0 0
Egypt
State/province [22] 0 0
Bani Suwayf
Country [23] 0 0
Egypt
State/province [23] 0 0
Cairo
Country [24] 0 0
Egypt
State/province [24] 0 0
Fayoum
Country [25] 0 0
Egypt
State/province [25] 0 0
Giza
Country [26] 0 0
Egypt
State/province [26] 0 0
Ismailia
Country [27] 0 0
France
State/province [27] 0 0
Calvados
Country [28] 0 0
France
State/province [28] 0 0
Nimes
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
Hungary
State/province [30] 0 0
Debrecen
Country [31] 0 0
Hungary
State/province [31] 0 0
Kecskemét
Country [32] 0 0
Hungary
State/province [32] 0 0
Szeged
Country [33] 0 0
Nepal
State/province [33] 0 0
Bagmati Province/ State 3
Country [34] 0 0
Nepal
State/province [34] 0 0
Maharajgung
Country [35] 0 0
Nepal
State/province [35] 0 0
Kathmandu
Country [36] 0 0
Netherlands
State/province [36] 0 0
Flevoland
Country [37] 0 0
Netherlands
State/province [37] 0 0
Gelderland
Country [38] 0 0
Netherlands
State/province [38] 0 0
Noord Holland
Country [39] 0 0
Netherlands
State/province [39] 0 0
Overijssel
Country [40] 0 0
Netherlands
State/province [40] 0 0
Zuid Holland
Country [41] 0 0
Netherlands
State/province [41] 0 0
's-Hertogenbosch
Country [42] 0 0
Netherlands
State/province [42] 0 0
Arnhem
Country [43] 0 0
Netherlands
State/province [43] 0 0
Den Haag
Country [44] 0 0
Netherlands
State/province [44] 0 0
Doetinchem
Country [45] 0 0
Netherlands
State/province [45] 0 0
Dordrecht
Country [46] 0 0
Netherlands
State/province [46] 0 0
Ede
Country [47] 0 0
Netherlands
State/province [47] 0 0
Goes
Country [48] 0 0
Netherlands
State/province [48] 0 0
Gouda
Country [49] 0 0
Netherlands
State/province [49] 0 0
Nijmegen
Country [50] 0 0
North Macedonia
State/province [50] 0 0
Bitola
Country [51] 0 0
North Macedonia
State/province [51] 0 0
Skopje
Country [52] 0 0
North Macedonia
State/province [52] 0 0
Tetovo
Country [53] 0 0
Serbia
State/province [53] 0 0
Belgrade
Country [54] 0 0
Serbia
State/province [54] 0 0
Sremska Kamenica
Country [55] 0 0
Spain
State/province [55] 0 0
Asturias
Country [56] 0 0
Spain
State/province [56] 0 0
Baleares
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Badalona
Country [59] 0 0
Spain
State/province [59] 0 0
Granada
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Vigo
Country [62] 0 0
Switzerland
State/province [62] 0 0
Geneva
Country [63] 0 0
Switzerland
State/province [63] 0 0
Luzern
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Dorset (county)
Country [65] 0 0
United Kingdom
State/province [65] 0 0
East Riding of Yorkshire (unitary authority)
Country [66] 0 0
United Kingdom
State/province [66] 0 0
East Sussex (county)
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Hertfordshire (county)
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Kent (county)
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Norfolk (county)
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Northamptonshire (county)
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Nottinghamshire (county)
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Surrey (county)
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Wiltshire (county)
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Middlesbrough
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Boston Scientific Corporation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Canadian Institutes of Health Research (CIHR)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Sanjit S Jolly, MD
Address 0 0
Population Health Research Institute
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)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03048825