CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 714 enrolled
Drug / intervention
Colchicine vs Placebodrug
Likely dose
Colchicine vs Placebo 1.8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02594111
NCT02594111Phase 4Completed
CompareCT.gov

Anti-inflammatory Therapy During Percutaneous Coronary Intervention

VA Office of Research and Development·interventional·Posted Nov 2, 2015·Updated Feb 21, 2023

In Brief

A Phase 4 clinical trial evaluating Colchicine vs Placebo for Coronary Artery Disease and Acute Coronary Syndrome. Completed, enrolled 714 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Acute Coronary Syndrome
CountriesUnited States
CollaboratorsNYU Langone Health

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2, 2015
Enrollment StartMay 30, 2013
Primary CompletionAug 30, 2019
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 10.7 years ago

Interventions

Colchicine vs Placebodrug

Colchicine vs Placebo 1.8 mg PO over 1 hour