CompletedPhase 3

Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

United States, Australia, Canada7,264 participantsStarted 2018-02-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major Adverse Cardiac Events (MACE)

Timeframe: up to 1 year

Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization

Timeframe: through study completion, an estimated average of 3 years

Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)

Timeframe: through study completion, an estimated average of 3 years

Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2)

Timeframe: through study completion, an estimated average of 3 years

Trial details

NCT IDNCT03048825

SponsorPopulation Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-09

View on ClinicalTrials.gov More ST Elevation Myocardial Infarction trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. 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

What they're measuring

Major Adverse Cardiac Events (MACE)

Timeframe: up to 1 year

Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization

Timeframe: through study completion, an estimated average of 3 years

Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)

Timeframe: through study completion, an estimated average of 3 years

Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2)

Timeframe: through study completion, an estimated average of 3 years