Anti-inflammatory Effects of Colchicine in PCI

• ClinicalTrials.gov Identifier: NCT01709981
• Recruitment Status: Completed
• First Posted: October 18, 2012
• Results First Posted: September 9, 2020
• Last Update Posted: May 25, 2022
• Sponsor: NYU Langone Health
• Collaborator: Takeda
• Information provided by (Responsible Party): NYU Langone Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Coronary Artery Disease
• Interventions: Drug: Colchicine; Drug: Placebo
• Enrollment: 280

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Colchicine	Placebo
Arm/Group Description	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 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
Period Title: Overall Study
Started	141	139
Completed	141	139
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Colchicine	Placebo	Total
Arm/Group Description		Colchicine	Placebo	Total of all reporting groups
Overall Number of Baseline Participants		141	139	280
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	141 participants	139 participants	280 participants
		64.31 (9.29)	65.15 (10.38)	64.7 (9.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	141 participants	139 participants	280 participants
	Female	11 7.8%	12 8.6%	23 8.2%
	Male	130 92.2%	127 91.4%	257 91.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	141 participants	139 participants	280 participants
	Hispanic or Latino	34 24.1%	30 21.6%	64 22.9%
	Not Hispanic or Latino	107 75.9%	109 78.4%	216 77.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	141 participants	139 participants	280 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	4 2.8%	11 7.9%	15 5.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	32 22.7%	25 18.0%	57 20.4%
	White	105 74.5%	102 73.4%	207 73.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	1 0.7%	1 0.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	141 participants	139 participants	280 participants
		141	139	280

Outcome Measures

1. Primary Outcome

Title	Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI
Description	[Not Specified]
Time Frame	30 minutes to 1 hour after PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	140	138
Median (Inter-Quartile Range); Unit of Measure: % change
	0; (-161 to 241)	20; (-99 to 282)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Equivalence
	Comments	Mann-Whitney
Statistical Test of Hypothesis	P-Value	0.31
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	2-sided

2. Secondary Outcome

Title	Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI
Description	[Not Specified]
Time Frame	baseline to 22-24 hr after PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	120	122
Median (Inter-Quartile Range); Unit of Measure: % change
	76; (-6 to 898)	338; (27 to 1264)

3. Secondary Outcome

Title	Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI
Description	[Not Specified]
Time Frame	baseline to 22-24 hr after PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	123	124
Median (Inter-Quartile Range); Unit of Measure: % change
	11; (-14 to 80)	66; (1 to 172)

4. Secondary Outcome

Title	Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI
Description	[Not Specified]
Time Frame	30 minutes to 1 hour after PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	140	138
Median (Inter-Quartile Range); Unit of Measure: % change
	0; (-2 to 9)	0; (-5 to 7)

5. Secondary Outcome

Title	Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI
Description	[Not Specified]
Time Frame	baseline to 22-24 hr after PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	120	122
Median (Inter-Quartile Range); Unit of Measure: % change
	0; (0 to 8)	0; (-9 to 6)

Adverse Events

Time Frame	30 days, 6 months, and yearly for 5 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Colchicine		Placebo
Arm/Group Description	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 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
All-Cause Mortality
	Colchicine		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/141 (0.00%)		0/139 (0.00%)
Serious Adverse Events
	Colchicine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/141 (1.42%)		6/139 (4.32%)
Cardiac disorders
Chest pain *	1/141 (0.71%)	1	1/139 (0.72%)	1
General disorders
Hemodynamic instabiity *	0/141 (0.00%)	0	2/139 (1.44%)	2
Bleeding *	0/141 (0.00%)	0	1/139 (0.72%)	1
Immune system disorders
Fever *	0/141 (0.00%)	0	1/139 (0.72%)	1
Renal and urinary disorders
Elevated creatinine *	0/141 (0.00%)	0	1/139 (0.72%)	1
Vascular disorders
Ischemic stroke *	1/141 (0.71%)	1	0/139 (0.00%)	0
* Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Colchicine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0.00%)		0/139 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Binita Shah
• Organization: NYU Langone Health
• Phone: 212-263-6631
• EMail: Binita.Shah@nyulangone.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shah B, Pillinger M, Zhong H, Cronstein B, Xia Y, Lorin JD, Smilowitz NR, Feit F, Ratnapala N, Keller NM, Katz SD. Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008717. doi: 10.1161/CIRCINTERVENTIONS.119.008717. Epub 2020 Apr 16.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01709981
• Other Study ID Numbers: 11-02573
• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Results First Submitted: July 23, 2020
• Results First Posted: September 9, 2020
• Last Update Posted: May 25, 2022