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Colchicine + Spironolactone after Stenting for Heart Attack (CLEAR SYNERGY Trial)

Phase 3

Waitlist Available

Led By Sanjit S Jolly, MD

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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 specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an estimated average of 2 years

Awards & highlights

CLEAR SYNERGY Trial Summary

This 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 is the study for?

This trial is for adults who've had a heart attack and are getting PCI (a procedure to open blocked arteries) within 48 hours of symptom onset. They must not be pregnant, breastfeeding, or have conditions like severe liver disease, low blood pressure, active diarrhea, known allergies to the stent/drugs used in the trial or unable to take dual antiplatelet therapy.Check my eligibility

What is being tested?

The study looks at how well patients recover from a heart attack after getting a SYNERGY stent and taking either colchicine and spironolactone or placebos. It's checking if treating both the main artery blockage with a stent and other risky areas with medication helps more than just the stent alone.See study design

What are the potential side effects?

Colchicine can cause digestive issues like diarrhea or nausea; spironolactone may lead to high potassium levels, kidney problems, or hormonal changes such as breast enlargement in men. The SYNERGY stent could potentially cause allergic reactions.

CLEAR SYNERGY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a severe heart attack and am getting a stent within 12 hours of it starting.

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I had a heart attack without ST elevation and received a stent after high troponin levels.

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I had a severe heart attack and was treated within 48 hours, but I'm not in the SYNERGY stent study.

CLEAR SYNERGY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an estimated average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an estimated average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an estimated average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of cardiovascular death or new or worsening heart failure

Composite of cardiovascular death, recurrent myocardial infarction, or stroke

Major Adverse Cardiac Events (MACE)

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981

Chest pain

Ischemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

Colchicine

Placebo

CLEAR SYNERGY Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Spironolactone +/- SYNERGY StentExperimental Treatment3 Interventions

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.

Group II: Colchicine +/- SYNERGY StentExperimental Treatment3 Interventions

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.

Group III: Colchicine + Spironolactone +/- SYNERGY StentExperimental Treatment3 Interventions

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.

Group IV: Placebo +/- SYNERGY StentPlacebo Group3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colchicine

FDA approved

Spironolactone

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

672,849 Total Patients Enrolled

18 Trials studying Myocardial Infarction

142,243 Patients Enrolled for Myocardial Infarction

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,340 Previous Clinical Trials

26,445,635 Total Patients Enrolled

17 Trials studying Myocardial Infarction

1,150,420 Patients Enrolled for Myocardial Infarction

Boston Scientific CorporationIndustry Sponsor

718 Previous Clinical Trials

925,885 Total Patients Enrolled

12 Trials studying Myocardial Infarction

9,427 Patients Enrolled for Myocardial Infarction

Media Library

Colchicine Clinical Trial Eligibility Overview. Trial Name: NCT03048825 — Phase 3

Myocardial Infarction Research Study Groups: Colchicine + Spironolactone +/- SYNERGY Stent, Spironolactone +/- SYNERGY Stent, Colchicine +/- SYNERGY Stent, Placebo +/- SYNERGY Stent

Myocardial Infarction Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT03048825 — Phase 3

Colchicine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03048825 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients presently being recruited for this clinical trial?

"From the information provided by clinicaltrials.gov, it can be gathered that this study is still recruiting patients. The study was originally posted on February 1st, 2018, and was last edited on August 9th, 2022. They are looking for 7000 patients from 1 location."

Answered by AI

What are some of the most common medical conditions that Colchicine is used to manage?

"While most commonly used for gout flares, Colchicine can also be taken to manage primary hyperaldosteronism, behcet's syndrome, and cirrhosis of the liver."

Answered by AI