Trials / Completed
CompletedNCT03048825
Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 7,264 (actual)
- Sponsor
- Population Health Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This is a multicenter, international SYNERGY stent registry that is embedded within a randomized, blinded, double-dummy, 2x2 factorial design trial of colchicine versus placebo and spironolactone versus placebo in patients with myocardial infarction who have undergone primary percutaneous coronary intervention (PCI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Colchicine-Placebo | Matching Colchicine-placebo once daily |
| DRUG | Spironolactone-Placebo | Matching Spironolactone-Placebo once daily |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2024-08-09
- Completion
- 2024-08-09
- First posted
- 2017-02-09
- Last updated
- 2024-10-15
Locations
109 sites across 14 countries: United States, Australia, Canada, Czechia, Egypt, France, Hungary, Nepal, Netherlands, North Macedonia, Serbia, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03048825. Inclusion in this directory is not an endorsement.