Table 2.
Major ongoing clinical trials involving anti-inflammatory agents in atherosclerotic heart disease.
| Trial name | Study design | Study population | Estimated enrollment | Estimated completion date | Intervention | Target | Primary outcomes | ClinicalTrials.gov identifier: |
|---|---|---|---|---|---|---|---|---|
| Therapy with a clear target | ||||||||
| CLEVER-ACS trial | Phase I–II, randomized, paralleled, placebo-controlled trial | Patients with STEMI | 150 | December 31, 2020 | Everolimus (7.5 mg for 3 days, followed By 5 mg for 2 days) | mTOR | Myocardial infarct size | NCT01529554 |
| Broad-spectrum anti-inflammatory approach | ||||||||
| ALL-HEART study (93) | Multicenter, controlled, prospective, randomized, open-label blinded | Patients aged 60 years and older with ihd | 5,215 | Unknown | Allopurinol (up to 600 mg daily) | Multiple | Composite of nonfatal myocardial infarction, nonfatal stroke or cardiovascular death | ISRCTN32017426 |
| COACS: Colchicine for Acute Coronary Syndromes | Phase III multicenter, double blind, randomized placebo-controlled | Patients with ACS (unstable angina or acute myocardial infarction) | 500 | Unknown | Colchicine 0.5 Mg/day vs. Placebo | Multiple | Overall mortality, new acute coronary syndrome, and ischemic stroke | NCT01906749 |
| Colchicine and Spironolactone in patients with STEMI/SYNERGY Stent Registry | Phase III randomized placebo-controlled 4 study arms, 2 × 2 factorial design | Patients with MI/SYNERGY Stent Registry | 7,000 | March 30, 2025 | Colchicine 1 mg/day And/or Spironolactone 25 mg/day and/or placebo and/or synergy stent | Multiple | Major Adverse Cardiac Events for SYNERGY Stent (defined as the composite of death, recurrent target vessel MI, stroke, or ischemia driven target vessel revascularization) | NCT03048825 |
| CONVINCE | Phase III multicenter, Open-label, placebo controlled | Patients older than 40 years of age who have suffered an ischemic stroke or transient ischemic attack not caused by cardiac embolism or other defined causes | 2,623 | October 2021 | Colchicine 0.5 mg/day vs. placebo | Multiple | Nonfatal recurrent ischemic stroke and coronary events and vascular death | NCT02898610 |
CI, confidence interval; HR, hazard ratio; MI, myocardial infarction; STEMI, ST-segment elevation myocardial infarction; ACS, acute coronary syndrome; mTOR, mechanistic target of rapamycin; IHD, ischemic heart disease.