Table 1.

Randomized clinical trials that have tested the use of colchicine in coronary artery disease.

Trial	Year of Study	Nº of Patients	Inclusion Criteria	Investigated Drug	Primary Outcomes	Results
Nidorf et al. * [21]	2013	532	Patients with chronic coronary disease using statins and standard secondary prevention therapy	Colchicine 0.5 mg o.d. vs. no colchicine	ACS, out-of-hospital cardiac arrest, and/or non-cardioembolic ischemic stroke	After a median of 36 months, 5.3% of patients in the colchicine group had a primary outcome versus 15% in the no colchicine group (HR 0.33, 95% CI 0.18–0.59; p < 0.001).
Martínez et al. [22]	2015	83	Patients with ACS (excluding STEMI), stable CAD, and controls (no evidence of lesions) who would undergo coronary angiography	Colchicine 1 mg o.d. vs. placebo	Assessment of IL-1β, IL-6, and IL-18 levels in coronary arteries	Colchicine significantly reduced the transcoronary gradients of these markers in patients with ACS (p = 0.028, 0.032, and 0.032, for IL-1b, IL-18, and IL-6, respectively). There was no difference for those with stable CAD.
Akodad et al. [23]	2017	44	Patients with STEMI who underwent an angioplasty of the culprit lesion	Colchicine 1 mg o.d. + OMT vs. OMT	CRP peak assessment during hospitalization	No significant difference in CRP peak between those who used or did not use colchicine (29.03 mg/L × 21.86 mg/L, respectively, p = 0.86).
Tardif et al. [18]	2019	4745	Patients who had AMI within 30 days and were treated with PCI and were using statins and OMT	Colchicine 0.5 mg o.d. vs. placebo	Cardiovascular death, CPR, AMI, stroke, or hospitalization for angina with subsequent revascularization	Colchicine reduced the primary endpoint (HR 0.77, 95% CI 0.61–0.96, p = 0.02) at 19.6 months of follow-up.
Tong et al. [24]	2020	795	Patients with ACS and evidence of CAD on coronary angiography who were treated with PCI or medical therapy	Colchicine 0.5 mg b.i.d. for 30 days followed by 0.5 mg o.d. vs. placebo	Death for any cause, ACS, ischemia-driven urgent revascularization, and stroke	Over the 12-month follow-up period, there was no significant difference in primary endpoint between the two groups (24 (6.1%) in the colchicine group versus 38 (9.5%) in the placebo group).
Nidorf et al. [25]	2020	5572	Patients with stable CAD receiving OMT for at least six months (catheterization or coronary CT angiography with significant lesion or calcium score with Agatston score > 400)	Colchicine 0.5 mg o.d. vs. placebo	Cardiovascular death, spontaneous AMI, stroke, and coronary revascularization	After 28.6 months, colchicine reduced the primary endpoint (HR 0.69, 95% CI 0.57–0.83, p < 0.001).
Shah et al. [26]	2020	400	Patients with stable CAD who would undergo coronary angioplasty	Colchicine 1.8 mg o.d. vs. placebo	Evaluation of myocardial injury reduction after angioplasty	No difference in myocardial injury related to angioplasty. No differences in the secondary endpoint of MACE reduction at 30 days. There was an attenuation in the increase in IL-6 and CRP in the colchicine group within 24 h after the procedure.

ACS: acute coronary syndrome; AMI: acute myocardial infarction; CAD: coronary artery disease; CPR: cardiopulmonary resuscitation; CRP: C-reactive protein; MACE: major adverse cardiac event; PCI: percutaneous coronary intervention; OMT: optimized medical treatment; STEMI: ST elevation myocardial infarction. * This study was an open-label trial with blinded endpoint adjudication (a PROBE design).