Trial Outcomes & Findings for Colchicine in Percutaneous Coronary Intervention (NCT NCT02594111)

NCT ID: NCT02594111

Last Updated: 2023-02-21

Results Overview

troponin above the upper limit of normal (ULN)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 714 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2023-02-21

Participant Flow

Participant milestones

Measure	Colchicine Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
Overall Study STARTED	366	348
Overall Study COMPLETED	366	348
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Colchicine in Percutaneous Coronary Intervention

Baseline characteristics by cohort

Measure	Colchicine n=366 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=348 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Total n=714 Participants Total of all reporting groups
Age, Continuous	66.1 years STANDARD_DEVIATION 9.7 • n=5 Participants	65.8 years STANDARD_DEVIATION 10.7 • n=7 Participants	65.9 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	336 Participants n=5 Participants	324 Participants n=7 Participants	660 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	75 Participants n=5 Participants	79 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	291 Participants n=5 Participants	269 Participants n=7 Participants	560 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	85 Participants n=5 Participants	75 Participants n=7 Participants	160 Participants n=5 Participants
Race (NIH/OMB) White	268 Participants n=5 Participants	253 Participants n=7 Participants	521 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	366 Participants n=5 Participants	348 Participants n=7 Participants	714 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

troponin above the upper limit of normal (ULN)

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
Number of Participants With Peri-procedural Myocardial Necrosis	118 Participants	122 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)	23 Participants	25 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR	35 Participants	36 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
All-cause Mortality, Non-fatal MI, or TVR	48 Participants	48 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
All-cause Mortality, Non-fatal MI, or TVR	57 Participants	57 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
All-cause Mortality, Non-fatal MI, or TVR	65 Participants	63 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
All-cause Mortality, Non-fatal MI, or TVR	67 Participants	67 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

SCAI definition

Outcome measures

Measure	Colchicine n=206 Participants Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=194 Participants Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
Number of Participants With Peri-procedural Myocardial Infarction (MI)	6 Participants	9 Participants

Adverse Events

Colchicine

Serious events: 72 serious events

Other events: 67 other events

Deaths: 26 deaths

Placebo

Serious events: 79 serious events

Other events: 36 other events

Deaths: 29 deaths

Serious adverse events

Measure	Colchicine n=366 participants at risk Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=348 participants at risk Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
Gastrointestinal disorders GI distress	0.27% 1/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.00% 0/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Cardiac disorders Chest pain	0.27% 1/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.57% 2/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Injury, poisoning and procedural complications Access site discomfort	0.00% 0/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.29% 1/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
General disorders Hemodynamic instability	0.00% 0/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.57% 2/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Immune system disorders Fever	0.00% 0/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.57% 2/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Renal and urinary disorders Elevated creatinine	0.27% 1/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.57% 2/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Vascular disorders Ischemic stroke	0.27% 1/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.00% 0/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
General disorders Fluid overload	0.27% 1/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.29% 1/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
General disorders Bleeding	0.00% 0/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	0.57% 2/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Cardiac disorders all-cause mortality	12.6% 26/206 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	14.9% 29/194 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Cardiac disorders myocardial infarction	8.7% 18/206 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	9.8% 19/194 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Cardiac disorders target vessel revascularization	7.8% 16/206 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	7.2% 14/194 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Cardiac disorders PCI-related myocardial infarction	11.2% 23/206 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	11.9% 23/194 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.

Other adverse events

Measure	Colchicine n=366 participants at risk Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour	Placebo n=348 participants at risk Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
Cardiac disorders Chest pain	9.0% 33/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	7.2% 25/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.
Gastrointestinal disorders Gastrointestinal symptoms	9.3% 34/366 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.	3.2% 11/348 • For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years Note that all AEs except for death, myocardial infarction, and target vessel revascularization were recorded for all patients (n=714), while death, myocardial infarction, and target vessel revascularization were only recorded for those undergoing percutaneous coronary intervention (n=400) and so the at risk numbers are different.

Additional Information

Dr. Binita Shah

VA NY Harbor Healthcare System

Phone: 212-686-7500

Email: binita.shah@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place