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Anti-inflammatory Effects of Colchicine in PCI

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ClinicalTrials.gov Identifier: NCT01709981
Recruitment Status : Active, not recruiting
First Posted : October 18, 2012
Results First Posted : September 9, 2020
Last Update Posted : July 1, 2021
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Binita Shah, 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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Colchicine Placebo
Hide 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
Arm/Group Title Colchicine Placebo Total
Hide Arm/Group Description Colchicine Placebo Total of all reporting groups
Overall Number of Baseline Participants 141 139 280
Hide 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
1.Primary Outcome
Title Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI
Hide Description [Not Specified]
Time Frame 30 minutes to 1 hour after PCI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame baseline to 22-24 hr after PCI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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
Hide Description [Not Specified]
Time Frame baseline to 22-24 hr after PCI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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
Hide Description [Not Specified]
Time Frame 30 minutes to 1 hour after PCI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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
Hide Description [Not Specified]
Time Frame baseline to 22-24 hr after PCI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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)
Time Frame 30 days, 6 months, and yearly for 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Colchicine Placebo
Hide 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%)    
Hide 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
Hide 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%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Binita Shah
Organization: NYU Langone Health
Phone: 212-263-6631
EMail: Binita.Shah@nyulangone.org
Layout table for additonal information
Responsible Party: Binita Shah, 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: July 1, 2021