Colchicine in Percutaneous Coronary Intervention (Colchicine-PCI)
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ClinicalTrials.gov Identifier: NCT02594111 |
Recruitment Status :
Completed
First Posted : November 1, 2015
Results First Posted : July 10, 2020
Last Update Posted : February 21, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease Acute Coronary Syndrome | Drug: Colchicine vs Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 714 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Anti-inflammatory Therapy During Percutaneous Coronary Intervention |
Actual Study Start Date : | May 30, 2013 |
Actual Primary Completion Date : | August 30, 2019 |
Actual Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Colchicine
Colchicine 1.8 mg PO over 1 hour
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Drug: Colchicine vs Placebo
Colchicine vs Placebo 1.8 mg PO over 1 hour |
Placebo Comparator: Placebo
Matching placebo
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Drug: Colchicine vs Placebo
Colchicine vs Placebo 1.8 mg PO over 1 hour |
- Number of Participants With Peri-procedural Myocardial Necrosis [ Time Frame: 24 hours ]troponin above the upper limit of normal (ULN)
- Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR) [ Time Frame: 30 days ]all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
- Number of Participants With All-cause Mortality, Non-fatal MI, or TVR [ Time Frame: 1 year ]all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
- All-cause Mortality, Non-fatal MI, or TVR [ Time Frame: 2 years ]all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
- All-cause Mortality, Non-fatal MI, or TVR [ Time Frame: 3 years ]all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
- All-cause Mortality, Non-fatal MI, or TVR [ Time Frame: 4 years ]all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
- All-cause Mortality, Non-fatal MI, or TVR [ Time Frame: 5 years ]all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
- Number of Participants With Peri-procedural Myocardial Infarction (MI) [ Time Frame: 24 hours ]SCAI definition
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Referred for possible PCI
Exclusion Criteria:
- Colchicine use within 1 month
- History of colchicine intolerance
- Glomerular filtration rate <30mL/minute or on dialysis (due to the need to adjust colchicine dose in this setting)
- Active malignancy or infection (major confounder with increased inflammatory markers)
- History of myelodysplasia (due to suggested cautionary use of colchicine in this setting)
- High-dose statin load <24 hours prior to procedure (major confounder that is known to reduce inflammatory levels in 12 to 24 hours)
- Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual drug
- Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil, again due to drug interactions)
- Unable to consent
- Participating in a competing study
- Any significant condition or situation that may put the subject at higher risk, confound the study results or interfere with adherence to study procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594111
United States, New York | |
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | |
New York, New York, United States, 10010 |
Principal Investigator: | Binita Shah, MD | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY |
Documents provided by VA Office of Research and Development:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT02594111 |
Other Study ID Numbers: |
CARB-025-15S |
First Posted: | November 1, 2015 Key Record Dates |
Results First Posted: | July 10, 2020 |
Last Update Posted: | February 21, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
inflammation percutaneous coronary intervention coronary artery disease colchicine |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |