A study of colchicine and spironolactone in patients who have had a heart attack.

CLEAR SYNERGY (OASIS 9) 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 - CLEAR SYNERGY (OASIS 9)

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000487-15-CZ

Enrollment

7000

Registered

2019-11-18

Start date

2020-04-29

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction (MI) MedDRA version: 20.0 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10064347 Term: Non ST segment elevation myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: spironolactone Pharmaceutical Form: Coated tablet INN or Proposed INN: SPIRONOLACTONE CAS Number: 52-01-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

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 = 200x ULN or Troponin > or = 100x ULN who have undergone PCI with one of the following: i. LVEF60 years 2. Able to be enrolled/randomized within 72 hours of index PCI and during initial hospitalization (however patients should be randomized as soon as possible after PCI) 3. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2625 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4375

Exclusion criteria

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 5.0 mew/L

Design outcomes

Primary

Measure	Time frame
Main Objective: In patients with MI who have undergone PCI, the primary objectives of this study is to determine: 1. If colchicine can reduce the incidence of cardiovascular (CV) death, myocardial infarction (MI), or stroke over duration of follow-up. 2. If spironolactone can reduce the incidence of CV death or new or worsening heart failure over duration of follow-up. 3. The rate of major adverse cardiac events (MACE) in patients who have received a SYNERGY everolimus-eluting stent compared to performance goal.;Secondary Objective: Not applicable;Primary end point(s): In patients with MI who have undergone PCI, the primary objectives of this study is to determine: 1. Colchicine vs. placebo: Time-to-event of the composite of cardiovascular death, recurrent MI, stroke, or unplanned ischemia driven revascularization, over the duration of follow-up. 2. Spironolactone vs. placebo: Total composite events of CV death or new or worsening heart failure over duration of follow-up. 3. SYNERGY Stent: MACE (defined as the composite of CV death, recurrent MI, or unplanned ischemia driven target vessel revascularization) for SYNERGY stent compared to a historical performance goal within 1 year. ;Timepoint(s) of evaluation of this end point: Time-to-event over duration of follow-up. Minimum follow-up of 1 year to maximum of 5 years (average of 3 years).	—

Measure

Time frame

Main Objective: In patients with MI who have undergone PCI, the primary objectives of this study is to determine: 1. If colchicine can reduce the incidence of cardiovascular (CV) death, myocardial infarction (MI), or stroke over duration of follow-up. 2. If spironolactone can reduce the incidence of CV death or new or worsening heart failure over duration of follow-up. 3. The rate of major adverse cardiac events (MACE) in patients who have received a SYNERGY everolimus-eluting stent compared to performance goal.;Secondary Objective: Not applicable;Primary end point(s): In patients with MI who have undergone PCI, the primary objectives of this study is to determine: 1. Colchicine vs. placebo: Time-to-event of the composite of cardiovascular death, recurrent MI, stroke, or unplanned ischemia driven revascularization, over the duration of follow-up. 2. Spironolactone vs. placebo: Total composite events of CV death or new or worsening heart failure over duration of follow-up. 3. SYNERGY Stent: MACE (defined as the composite of CV death, recurrent MI, or unplanned ischemia driven target vessel revascularization) for SYNERGY stent compared to a historical performance goal within 1 year. ;Timepoint(s) of evaluation of this end point: Time-to-event over duration of follow-up. Minimum follow-up of 1 year to maximum of 5 years (average of 3 years).

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Secondary

Measure	Time frame
Secondary end point(s): 1. COLCHICINE VS. COLCHICINE-PLACEBO: a) Time-to-event of the composite of cardiovascular death, recurrent MI, or stroke, over the duration of follow-up. b) Total events for the composite of cardiovascular death, recurrent MI, stroke, or unplanned ischemia driven revascularization over the duration of follow-up. 2. SPIRONOLACTONE VS. SPIRONOLACTONE-PLACEBO: a) Time-to-event of cardiovascular death or new or worsening heart failure over the duration of follow-up. b) Time-to-event of cardiovascular death over the duration of follow-up. c) Time-to-event of the composite of cardiovascular death, new or worsening heart failure or significant ventricular arrhythmia over the duration of follow-up. 3. COMBINED COLCHICINE AND SPIRONOLACTONE: Time to event for the composite of cardiovascular death, recurrent MI, stroke, unplanned ischemia driven revascularization, or new or worsening heart failure over the duration of follow up. 4. SYNERGY STENT REGISTRY: Incidence of Definite Stent Thrombosis within 1 year. ;Timepoint(s) of evaluation of this end point: Time-to-event over duration of follow-up. Minimum follow-up of 1 year to maximum of 5 years (average of 3 years).	—

Measure

Time frame

Secondary end point(s): 1. COLCHICINE VS. COLCHICINE-PLACEBO: a) Time-to-event of the composite of cardiovascular death, recurrent MI, or stroke, over the duration of follow-up. b) Total events for the composite of cardiovascular death, recurrent MI, stroke, or unplanned ischemia driven revascularization over the duration of follow-up. 2. SPIRONOLACTONE VS. SPIRONOLACTONE-PLACEBO: a) Time-to-event of cardiovascular death or new or worsening heart failure over the duration of follow-up. b) Time-to-event of cardiovascular death over the duration of follow-up. c) Time-to-event of the composite of cardiovascular death, new or worsening heart failure or significant ventricular arrhythmia over the duration of follow-up. 3. COMBINED COLCHICINE AND SPIRONOLACTONE: Time to event for the composite of cardiovascular death, recurrent MI, stroke, unplanned ischemia driven revascularization, or new or worsening heart failure over the duration of follow up. 4. SYNERGY STENT REGISTRY: Incidence of Definite Stent Thrombosis within 1 year. ;Timepoint(s) of evaluation of this end point: Time-to-event over duration of follow-up. Minimum follow-up of 1 year to maximum of 5 years (average of 3 years).

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Countries

Australia, Canada, Czechia, Czech Republic, Finland, France, Hungary, Netherlands, North Macedonia, Serbia, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactCLEAR SYNERGY Project Office

Population Health Research Institute

clear@phri.ca19055274322 xt. 40513

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026