Trial Outcomes & Findings for Anti-inflammatory Effects of Colchicine in PCI (NCT NCT01709981)

NCT ID: NCT01709981

Last Updated: 2022-05-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 280 participants
• Primary outcome timeframe: 30 minutes to 1 hour after PCI
• Results posted on: 2022-05-25

Participant Flow

Participant milestones

Measure	Colchicine 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later	Placebo Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Overall Study STARTED	141	139
Overall Study COMPLETED	141	139
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-inflammatory Effects of Colchicine in PCI

Baseline characteristics by cohort

Measure	Colchicine n=141 Participants Colchicine	Placebo n=139 Participants Placebo	Total n=280 Participants Total of all reporting groups
Age, Continuous	64.31 years STANDARD_DEVIATION 9.29 • n=5 Participants	65.15 years STANDARD_DEVIATION 10.38 • n=7 Participants	64.7 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	127 Participants n=7 Participants	257 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants n=5 Participants	109 Participants n=7 Participants	216 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	4 Participants n=5 Participants	11 Participants n=7 Participants	15 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	32 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) White	105 Participants n=5 Participants	102 Participants n=7 Participants	207 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	141 participants n=5 Participants	139 participants n=7 Participants	280 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes to 1 hour after PCI

Outcome measures

Measure	Colchicine n=140 Participants 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later	Placebo n=138 Participants Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI	0 % change Interval -161.0 to 241.0	20 % change Interval -99.0 to 282.0

SECONDARY outcome

Timeframe: baseline to 22-24 hr after PCI

Outcome measures

Measure	Colchicine n=120 Participants 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later	Placebo n=122 Participants Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI	76 % change Interval -6.0 to 898.0	338 % change Interval 27.0 to 1264.0

SECONDARY outcome

Timeframe: baseline to 22-24 hr after PCI

Outcome measures

Measure	Colchicine n=123 Participants 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later	Placebo n=124 Participants Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI	11 % change Interval -14.0 to 80.0	66 % change Interval 1.0 to 172.0

SECONDARY outcome

Timeframe: 30 minutes to 1 hour after PCI

Outcome measures

Measure	Colchicine n=140 Participants 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later	Placebo n=138 Participants Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI	0 % change Interval -2.0 to 9.0	0 % change Interval -5.0 to 7.0

SECONDARY outcome

Timeframe: baseline to 22-24 hr after PCI

Outcome measures

Measure	Colchicine n=120 Participants 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later	Placebo n=122 Participants Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI	0 % change Interval 0.0 to 8.0	0 % change Interval -9.0 to 6.0

Adverse Events

Colchicine

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Colchicine n=141 participants at risk 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later	Placebo n=139 participants at risk Placebo 1-2 hours prior PCI, followed by placebo 1 hour later Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Cardiac disorders Chest pain	0.71% 1/141 • Number of events 1 • 30 days, 6 months, and yearly for 5 years	0.72% 1/139 • Number of events 1 • 30 days, 6 months, and yearly for 5 years
Vascular disorders Ischemic stroke	0.71% 1/141 • Number of events 1 • 30 days, 6 months, and yearly for 5 years	0.00% 0/139 • 30 days, 6 months, and yearly for 5 years
Immune system disorders Fever	0.00% 0/141 • 30 days, 6 months, and yearly for 5 years	0.72% 1/139 • Number of events 1 • 30 days, 6 months, and yearly for 5 years
General disorders Hemodynamic instabiity	0.00% 0/141 • 30 days, 6 months, and yearly for 5 years	1.4% 2/139 • Number of events 2 • 30 days, 6 months, and yearly for 5 years
Renal and urinary disorders Elevated creatinine	0.00% 0/141 • 30 days, 6 months, and yearly for 5 years	0.72% 1/139 • Number of events 1 • 30 days, 6 months, and yearly for 5 years
General disorders Bleeding	0.00% 0/141 • 30 days, 6 months, and yearly for 5 years	0.72% 1/139 • Number of events 1 • 30 days, 6 months, and yearly for 5 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Binita Shah

NYU Langone Health

Phone: 212-263-6631

Email: Binita.Shah@nyulangone.org

Results disclosure agreements

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