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Colchicine and Spironolactone in Patients With MI / SYNERGY Stent Registry (CLEAR SYNERGY)

Primary Purpose

ST Elevation Myocardial Infarction, Non ST Elevation Myocardial Infarction

Status

Active

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Colchicine

Spironolactone

SYNERGY Bioabsorbable Polymer Drug-Eluting Stent

Colchicine-Placebo

Spironolactone-Placebo

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Able to be enrolled/randomized within 72 hours of index PCI (however patients should be randomized as soon as possible after PCI)
Written informed consent

Exclusion Criteria:

Age ≤18 years
Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
Any medical, geographic, or social factor making study participation impractical or precluding required follow-up
Systolic blood pressure <90 mm Hg
Active diarrhea
Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components
Unable to receive dual antiplatelet therapy
Any contraindication or known intolerance to colchicine or spironolactone
Requirement for colchicine or mineralocorticoid antagonist for another indication
History of cirrhosis or current severe hepatic disease
Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics
Creatinine clearance <30 mL/min/1.73 m2
Serum Potassium >5.0 meq/L

Sites / Locations

Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine + Spironolactone +/- SYNERGY Stent

Spironolactone +/- SYNERGY Stent

Colchicine +/- SYNERGY Stent

Placebo +/- SYNERGY Stent

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Composite of cardiovascular death, recurrent myocardial infarction, or stroke

The first occurrence of cardiovascular death, recurrent myocardial infarction, or stroke in the colchicine comparison

Composite of cardiovascular death or new or worsening heart failure

The first occurrence of cardiovascular death or new or worsening heart failure in the spironolactone comparison

Secondary Outcome Measures

Full Information

NCT ID

NCT03048825

First Posted

February 3, 2017

Last Updated

June 1, 2023

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR), Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03048825

Brief Title

Colchicine and Spironolactone in Patients With MI / SYNERGY Stent Registry

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR), Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST Elevation Myocardial Infarction, Non ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double-dummy masking of colchicine and spironolactone in 2x2 factorial

Allocation

Randomized

Enrollment

7063 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colchicine + Spironolactone +/- SYNERGY Stent

Arm Type

Experimental

Arm Description

Arm Title

Spironolactone +/- SYNERGY Stent

Arm Type

Experimental

Arm Description

Arm Title

Colchicine +/- SYNERGY Stent

Arm Type

Experimental

Arm Description

Arm Title

Placebo +/- SYNERGY Stent

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Colchicine

Intervention Description

Colchicine 0.5 mg once daily

Intervention Type

Drug

Intervention Name(s)

Spironolactone

Intervention Description

Spironolactone 25 mg once daily

Intervention Type

Device

Intervention Name(s)

SYNERGY Bioabsorbable Polymer Drug-Eluting Stent

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Colchicine-Placebo

Intervention Description

Matching Colchicine-placebo once daily

Intervention Type

Drug

Intervention Name(s)

Spironolactone-Placebo

Intervention Description

Matching Spironolactone-Placebo once daily

Primary Outcome Measure Information:

Title

Major Adverse Cardiac Events (MACE)

Description

Time Frame

up to 1 year

Title

Composite of cardiovascular death, recurrent myocardial infarction, or stroke

Description

The first occurrence of cardiovascular death, recurrent myocardial infarction, or stroke in the colchicine comparison

Time Frame

through study completion, an estimated average of 2 years

Title

Composite of cardiovascular death or new or worsening heart failure

Description

The first occurrence of cardiovascular death or new or worsening heart failure in the spironolactone comparison

Time Frame

through study completion, an estimated average of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Able to be enrolled/randomized within 72 hours of index PCI (however patients should be randomized as soon as possible after PCI) Written informed consent Exclusion Criteria: Age ≤18 years Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception Any medical, geographic, or social factor making study participation impractical or precluding required follow-up Systolic blood pressure <90 mm Hg Active diarrhea Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components Unable to receive dual antiplatelet therapy Any contraindication or known intolerance to colchicine or spironolactone Requirement for colchicine or mineralocorticoid antagonist for another indication History of cirrhosis or current severe hepatic disease Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics Creatinine clearance <30 mL/min/1.73 m2 Serum Potassium >5.0 meq/L

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjit S Jolly, MD

Organizational Affiliation

Population Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L2X2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34269908

Citation

Bouabdallaoui N, Tardif JC. Colchicine in the Management of Acute and Chronic Coronary Artery Disease. Curr Cardiol Rep. 2021 Jul 16;23(9):120. doi: 10.1007/s11886-021-01560-w.

Results Reference

derived

PubMed Identifier

32648087

Citation

Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9.

Results Reference

derived

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Colchicine and Spironolactone in Patients With MI / SYNERGY Stent Registry

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