A study of colchicine and spironolactone in patients who have had a myocardial infarction.

CLEAR SYNERGY (OASIS 9) A 2x2 factorial randomized controlled trial of CoLchicine and spironolactonE in patients with ST elevation 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-FI

Enrollment

4000

Registered

2018-12-31

Start date

2019-03-14

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

ST segment elevation myocardial infarction

Interventions

Trade Name: spironolactone Product Name: spironolactone Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: colchicine

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 24 hours of symptom onset, not prospectively enrolled in SYNERGY STENT registry 2. Able to be randomized within 48 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 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2500

Exclusion criteria

Exclusion criteria: - Age =18 years - Pregnancy, breastfeeding, or women of childbaring potential who are not using an effective method of contraception - Any medical, geographic, or social factor making study participation impractical or precluding required folow-up - Systolic blood pressure 5.0 mew/L

Design outcomes

Primary

Measure	Time frame
Main Objective: In patients with STEMI 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: 1. Colchicine vs. placebo: Time-to-event of the composite of cardiovascular death, recurrent MI, unplanned ischemia driven revascularization, or stroke, over the duration of follow-up. 2. Spironolactone vs. placebo: a) Time-to-event of cardiovascular death over the duration of follow-up. b) 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 or new or worsening heart failure over follow up. 4. SYNERGY stent: Incidence of Definite Stent Thrombosis within 1 year;Primary end point(s): In patients with STEMI who have undergone PCI, the primary objectives of this study is to determine: 1. Colchicine vs. placebo: time to event of the composite of CV death, recurrent MI, or stroke over duration of follow-up. 2. Spironolactone vs. placebo: time to event of the composite 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 3 years (average of 2 years).	—

Measure

Time frame

Main Objective: In patients with STEMI 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: 1. Colchicine vs. placebo: Time-to-event of the composite of cardiovascular death, recurrent MI, unplanned ischemia driven revascularization, or stroke, over the duration of follow-up. 2. Spironolactone vs. placebo: a) Time-to-event of cardiovascular death over the duration of follow-up. b) 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 or new or worsening heart failure over follow up. 4. SYNERGY stent: Incidence of Definite Stent Thrombosis within 1 year;Primary end point(s): In patients with STEMI who have undergone PCI, the primary objectives of this study is to determine: 1. Colchicine vs. placebo: time to event of the composite of CV death, recurrent MI, or stroke over duration of follow-up. 2. Spironolactone vs. placebo: time to event of the composite 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 3 years (average of 2 years).

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Secondary

Measure	Time frame
Secondary end point(s): 1. COLCHINE VS. COLCHICINE-PLACEBO: Time-to-event of the composite of cardiovascular death, recurrent MI, unplanned ischemia driven revascularization, or stroke, over the duration of follow-up. 2. SPIRONOLACTONE VS. SPIRONOLACTONE-PLACEBO: a) Time-to-event of cardiovascular death over the duration of follow-up. b) 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 or new or worsening heart failure over 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 3 years (average of 2 years).	—

Measure

Time frame

Secondary end point(s): 1. COLCHINE VS. COLCHICINE-PLACEBO: Time-to-event of the composite of cardiovascular death, recurrent MI, unplanned ischemia driven revascularization, or stroke, over the duration of follow-up. 2. SPIRONOLACTONE VS. SPIRONOLACTONE-PLACEBO: a) Time-to-event of cardiovascular death over the duration of follow-up. b) 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 or new or worsening heart failure over 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 3 years (average of 2 years).

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Countries

Canada, Czech Republic, Finland, Hungary, Netherlands, Spain

Contacts

Public ContactPHRI

Population Health Research Institute

clear@phri.ca19055274322 x41079

Outcome results

None listed

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