Table 2.
Currently ongoing clinical trials studying colchicine in ischemic heart disease
| TRIAL | NCT No | Study design | Clinical setting | Interventions | Outcomes |
|---|---|---|---|---|---|
| CLEAR SYNERGY (OASIS 9) | NCT03048825 | Randomized, quadruple blinded, with factorial assignment | STEMI and high risk NSTEMI | Colchicine or spironolactone vs. placebo | Incidence of cardiovascular death, recurrent myocardial infarction, or stroke |
| CLEAR SINERGY Neutrophil Substudy | NCT03874338 | Observational, prospective | STEMI | Colchicine | Soluble L-selectin; other soluble markers of neutrophil activity; markers of systemic inflammation |
| COVERT-MI | NCT03156816 | Randomized, parallel, quadruple-blinded | MI | Colchicine vs. placebo | Infarct size (at CMR); LVEF; Microvascular obstruction |
| COPMAN | NCT04139655 | Randomized, parallel, triple-blinded | MI and myocardial injury in non-cardiac surgery | Colchicine 0.6 mg/day vs. placebo | Incidence of Myocardial Injury after Non- Cardiac Surgery (MINS); Adverse Events; infectious complications |
| DRC-04 | NCT03376698 | Randomized, parallel, quadruple-blinded | T2DM and CAD | Colchicine 0.5 mg/day or Colchicine 0.25 mg/day vs. placebo | Change in serum hs-CRP, FMD, adhesive ability of white blood cell and plasma myeloperoxidase level |
CAD coronary artery disease; CMR cardiac magnetic resonance; FMD flow-mediated dilatation; hs-CRP high sensitive C-reactive protein; LVEF left ventricle ejection fraction; MI myocardial infarction; NSTEMI Non ST Elevation Myocardial Infarction; STEMI ST Elevation Myocardial Infarction