Table 1.

Clinical trials targeting inflammation related to the NLRP3 inflammasome

Name of the study	Published	Indication	Sample size	Intervention	Outcome	Results	Ref
LoDoCo: Low-Dose Colchicine for Secondary Prevention of Cardiovascular Disease	2013	Stable coronary artery disease	532	Colchicine 0.5 mg/d (n = 282) vs. no colchicine (n = 250)	Composite incidence of ACS, OHCA, ischemic Stroke	Colchicine 5.3% primary outcome No colchicine 16.0% primary outcome	[52]
COLCOT: Colchicine Cardiovascular Outcomes Trial	2019	Recent myocardial infarction (within 30 days after MI)	4745	Colchicine 0.5 mg/d (n = 2366) vs. placebo (n = 2379)	Composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, urgent hospitalization for angina leading to coronary revascularization	Colchicine 5.5% primary outcome Placebo 7.1% primary outcome	[53]
CANTOS: Canakinumab Anti-inflammatory Thrombosis Outcome Study	2017	History of myocardial infarction and hsCRP of 2 mg or more	10,061	Canakinumab 50 mg/3 months (n = 2170) 150 mg/3 months (n = 2284) 300 mg/3 months (n = 2263) Placebo (n = 3344)	Nonfatal myocardial infarction, nonfatal stroke, cardiovascular death	Canakinumab 150 mg/3 months incidence primary endpoint 3.86 events per 100 person-years Placebo incidence primary endpoint 4.50 events per 100 person-years	[54]
LoDoCo2: Low-dose Colchicine for Secondary Prevention of Cardiovascular Disease	N/A	Stable coronary artery disease	5522	Colchicine 0.5 mg/d vs. Placebo	Composite of cardiovascular death, myocardial infarction, ischemic stroke, ischemia-driven revascularization	Expected to publish results in 2020	[55]
COACS: Colchicine for Acute Coronary Syndromes	N/A	Acute Coronary Syndrome	500	Colchicine 0.5 mg/d vs. Placebo	Overall mortality, new acute coronary syndrome, ischemic stroke	Unknown	[56]
CLEAR-SYNERGY: Colchicine and Sprionolactone in Patients with STEMI/SYNERGY stent registry	N/A	STEMI	4000	Colchicine 1 mg/day and/or spironolactone 24 mg/day and/or placebo and/or SYNERGY stent (2 × 2 factorial design)	Cardiovascular death, recurrent myocardial infarction or stroke in the colchicine comparison	Estimated completion 2021	[57]
VCU-ART/VCU-ART(2): Virginia Commonwealth University Anakinra Remodeling Trial	2010/2013	ST-Elevation Myocardial Infarction	10/30	Anakinra 100 mg/d (n = 16) vs. Placebo (n = 19)	Difference in interval change in the LV end-systolic volume index (LVESVi)	Trend towards reduced incidence of adverse remodeling/No observable benefits in LV remodeling or function	[58, 59]