Phase 4
Completed N=714
Colchicine in Percutaneous Coronary Intervention
Source: ClinicalTrials.gov NCT02594111 ↗Enrolled (actual)
714
Serious AEs
21.2%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With Peri-procedural Myocardial Necrosis — 118; 122 Participants — p=<0.05
◆ Published Evidence
Highly cited
182citations · ~30 / year
Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial.
Summary
Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. This research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.
Linked Publications (2)
-
Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial.
-
Neutrophil Activation and Adhesiveness in Coronary Artery Disease: Results From the COLCHICINE-PCI Biomarker Substudy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Peri-procedural Myocardial Necrosis |
118; 122 | <0.05 sig |
| SECONDARY Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR) |
23; 25 | — |
| SECONDARY Number of Participants With All-cause Mortality, Non-fatal MI, or TVR |
35; 36 | — |
| SECONDARY All-cause Mortality, Non-fatal MI, or TVR |
67; 67 | — |
| SECONDARY Number of Participants With Peri-procedural Myocardial Infarction (MI) |
6; 9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02594111) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.