Table 2.
Clinical Trials Testing Inflammasome Signaling Blockade in Atherothrombosis
| Trial (Ref. #) | Population (N) | Intervention | Duration | Main Outcomes |
|---|---|---|---|---|
| LoDoCo109 | Stable CAD (532) |
Colchicine 0.5 mg daily |
3 y (median) | ↓Cardiovascular events (CRP not reported) |
| LoDoCo2110 | Chronic, stable CAD (5,522) |
Colchicine 0.5 mg daily |
2.4 y (median) | ↓Ischemic events (CRP not reported) |
| COLCOT112 | Recent AMI (>30 d) (4,754) |
Colchicine 0.5 mg daily |
1.9 y (median) | ↓Cardiovascular ischemic events ↑Pneumonia (no effect on CRP beyond reduction seen in placebo; no effect on HF events) |
| MRC-ILA114 | Acute NSTEMI (<48 h) (182) |
Anakinra 100 mg daily | 2 wk treatment (1 y follow-up) |
↓CRP at 7 and 14 d (no effect on ischemic events at 30 d and 3 mo, but ↑at 1 y) |
| VCUART/ VCUART2108 |
Acute STEMI (<12 h) (40) |
Anakinra 100 mg daily | 2 wk treatment (3 mo follow-up) |
↓CRP, ↓ HF incidence (no effect on ischemic events) |
| VCUART3108 | Acute STEMI (<12 h) (99) |
Anakinra 100 mg once or twice daily | 2 wk treatment (1 y follow-up) |
↓CRP, ↓HF incidence, ↓HF hospitalization (no effect on ischemic events) |
| CANTOS Pilot115 | Well-controlled T2DM, high cardiovascular risk (556) |
Canakinumab 5/15/50/150 mg monthly | 4 mo | ↓CRP, ↓IL-6, ↓fibrinogen (no effect on glucose, lipids, and blood pressure) |
| CANTOS116 | Prior AMI (>30 d), CRP ≥2 mg/L (10,061) |
Canakinumab 50/150/300 mg every 3 mo | 3.7 y (median) | ↓CRP, ↓ischemic events, ↓HF hospitalization, ↑infection-related deaths, ↓cancer-related deaths, ↓rheumatologic diseases, ↓lung cancer |
AMI = acute myocardial infarction; CAD = coronary artery disease; CANTOS = Canakinumab Anti-inflammatory Thrombosis Outcomes Study; COLCOT = Colchicine Cardiovascular Outcome Trial; CRP = C-reactive protein; HF = heart failure; COVERT-MI = Colchicine for Left Ventricular Infarct Size Treatment in Acute Myocardial Infarction; LoDoCo = Low-Dose Colchicine; MI = myocardial infarction; MRC-ILA = Medical Royal Council InterLeukin-1 Antagonist; NSTEMI = non–ST-segment–elevation myocardial infarction; STEMI = ST-segment–elevation myocardial infarction; T2DM = type 2 diabetes mellitus; VUCART = Virginia Commonwealth University Anakinra Remodeling/Response Trial; other abbreviations as in Table 1.