Short-Term Outcomes of Early Administration of Colchicine in Non-ST Segment Elevation Myocardial Infarction Patients Treated With Drug-Eluting Stents.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Inflammation plays a central role in the pathophysiology of atherosclerosis and in the progression of coronary artery. Colchicine, an anti-inflammatory agent traditionally used for gout and pericarditis, has emerged as a potential therapy in cardiovascular disease due to its ability to inhibit microtubule polymerization and suppress interleukin-1β and the NLRP3 inflammasome pathway.

COLCOT and LoDoCo2 trails have demonstrated the efficacy of colchicine in reducing cardiovascular events in patients with coronary artery disease.

However, more recent trials, including OASIS 9 and COVERT-MI trials did not support the use of a short-term colchicine treatment at the acute phase of ST segment elevation myocardial infarction (STEMI) to reduce infarct size and improve outcomes. Limited data exist on the peri-procedural use of colchicine in non-ST elevation myocardial infarction patients undergoing PCI.

This study proposes to assess whether a loading dose of colchicine before PCI, followed by 3-months maintenance therapy, can improve short-term clinical outcomes and inflammatory markers in non- STEMI patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Colchicine in ST-elevation Myocardial Infarction

NCT01936285

Acute Myocardial Infarction

UNKNOWN PHASE4

COlchicine Improve EnDothElial Function in Non ST Elevation Myocardial Infarction Patients

NCT02095522

NSTEMI

WITHDRAWN NA

The Effect of Colchicine on Inflammation in ACS Patients

NCT06054100

Acute Coronary Syndrome STEMI

COMPLETED PHASE3

Effect of Colchicine in Patients With Myocardial Infarction

NCT04218786

Myocardium; Injury Myocardial Infarction Myocardial Ischemia

WITHDRAWN PHASE2

Anti-inflammatory Effects of Colchicine in PCI

NCT01709981

Coronary Artery Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non ST-Segment Elevation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colchicine group

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

Administration of Colchicine 1 day before and 90 days after PCI in Non-STEMI Patients

Control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo Regimen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colchicine

Administration of Colchicine 1 day before and 90 days after PCI in Non-STEMI Patients

Intervention Type DRUG

Placebo

Matching Placebo Regimen

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with Non-STEMI
* Undergoing PCI with drug-eluting stents

Exclusion Criteria

* Severe renal or hepatic dysfunction
* Colchicine hypersensitivity
* Active infection and active diarrhea.
* Gastrointestinal intolerance
* Pregnancy or breastfeeding.
* Cardiogenic shock

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No