Colchicine and Spironolactone in Patients With MI / SYNERGY Stent Registry

ST Elevation Myocardial Infarction Clinical Trial

— CLEAR SYNERGY  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03048825
• Other study ID #: CLSYN.1702
• Secondary ID: OASIS-9
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 1, 2018
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat myocardial infarction. These treatments address both the culprit artery (PCI with SYNERGY stent) as well as the non-culprit arteries (randomization to routine colchicine and spironolactone).

Description:

This is a multicenter, international SYNERGY stent registry that is embedded within a randomized, blinded, double-dummy, 2x2 factorial design trial of colchicine versus placebo and spironolactone versus placebo in patients with myocardial infarction who have undergone primary percutaneous coronary intervention (PCI).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7063
• Est. completion date: July 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non ST Elevation Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Colchicine
Colchicine 0.5 mg once daily
• Spironolactone
Spironolactone 25 mg once daily

Device:
• 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.

Drug:
• Colchicine-Placebo
Matching Colchicine-placebo once daily
• Spironolactone-Placebo
Matching Spironolactone-Placebo once daily

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Population Health Research Institute	Boston Scientific Corporation, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	Major Adverse Cardiac Events (MACE) for SYNERGY Stent (defined as the composite of death, recurrent target vessel MI, stroke, or ischemia driven target vessel revascularization) compared to performance goal	up to 1 year
Primary	Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization	The first occurrence of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization in the colchicine comparison	through study completion, an estimated average of 3 years
Primary	Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)	Total composite of cardiovascular death or new or worsening heart failure in the spironolactone comparison (co-primary 1)	through study completion, an estimated average of 3 years
Primary	Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2)	The first occurence of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke in the spironolactone comparison (co-primary 2)	through study completion, an estimated average of 3 years