Colchicine and Spironolactone in Patients With MI / SYNERGY Stent Registry (CLEAR SYNERGY)
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ClinicalTrials.gov Identifier: NCT03048825 |
Recruitment Status :
Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : June 5, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ST Elevation Myocardial Infarction Non ST Elevation Myocardial Infarction | Drug: Colchicine Drug: Spironolactone Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent Drug: Colchicine-Placebo Drug: Spironolactone-Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7063 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | double-dummy masking of colchicine and spironolactone in 2x2 factorial |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 1, 2018 |
Estimated Primary Completion Date : | May 30, 2024 |
Estimated Study Completion Date : | May 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Colchicine + Spironolactone +/- SYNERGY Stent
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. |
Drug: Colchicine
Colchicine 0.5 mg once daily Drug: Spironolactone Spironolactone 25 mg once daily Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent 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. |
Experimental: Spironolactone +/- SYNERGY Stent
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. |
Drug: Spironolactone
Spironolactone 25 mg once daily Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent 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. Drug: Colchicine-Placebo Matching Colchicine-placebo once daily |
Experimental: Colchicine +/- SYNERGY Stent
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. |
Drug: Colchicine
Colchicine 0.5 mg once daily Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent 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. Drug: Spironolactone-Placebo Matching Spironolactone-Placebo once daily |
Placebo Comparator: Placebo +/- SYNERGY Stent
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. |
Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
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. Drug: Colchicine-Placebo Matching Colchicine-placebo once daily Drug: Spironolactone-Placebo Matching Spironolactone-Placebo once daily |
- Major Adverse Cardiac Events (MACE) [ Time Frame: up to 1 year ]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 [ Time Frame: through study completion, an estimated average of 2 years ]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 [ Time Frame: through study completion, an estimated average of 2 years ]The first occurrence of cardiovascular death or new or worsening heart failure in the spironolactone comparison
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048825
Canada, Ontario | |
Hamilton General Hospital | |
Hamilton, Ontario, Canada, L8L2X2 |
Principal Investigator: | Sanjit S Jolly, MD | Population Health Research Institute |
Responsible Party: | Population Health Research Institute |
ClinicalTrials.gov Identifier: | NCT03048825 |
Other Study ID Numbers: |
CLSYN.1702 OASIS-9 ( Other Identifier: Population Health Research Institute ) |
First Posted: | February 9, 2017 Key Record Dates |
Last Update Posted: | June 5, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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.: | No |
Myocardial Infarction ST Elevation Myocardial Infarction Non-ST Elevated Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Colchicine Spironolactone Gout Suppressants |
Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents |