The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease (ECLIPSE)

August 5, 2025 updated by: Naveen Seecheran, The University of The West Indies

The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad and Tobago. The Pilot ECLIPSE Study.

The effects of colchicine on cardiovascular health in patients with stable coronary artery disease have been shown to be beneficial due to its anti-inflammatory properties. This present study aims to explore the effects of colchicine on platelet reactivity in patients with coronary artery disease on dual antiplatelet therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent landmark clinical trials on the use of colchicine in patients with chronic coronary artery disease has led to its implementation as an FDA approved drug for secondary prevention in patients with coronary artery disease. Colchicine exerts a range of anti inflammatory effects which plays a major role in reduction of atherosclerosis and prevention cardiovascular events. This current study aims to investigate the effect of colchicine on platelet reactivity in patients with stable coronary artery disease already on dual anticoagulants.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with stable coronary artery disease.
  • Patients older than 18 years of age.
  • Patients currently on dual anti platelets, aspirin and clopidogrel

Exclusion Criteria:

• Patients already on colchicine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colchicine 0.5mg po bd
Patients with coronary disease taking Colchicine 0.5mg twice-daily orally for two weeks
Drug: Colchicine 0.5 MG oral tablet twice daily
Blood samples will be collected from participants in 2 separate instances. Initially, a baseline VerifyNow P2Y12 PRU and Aspirin reaction unit test assay, followed by a subsequent repeat test 2-week after a 2-week, colchicine 0.5mg oral tablet twice-daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P2Y12 reaction units and Aspirin reaction units
Time Frame: two weeks
P2Y12 and Aspirin reaction units pre and post colchicine 0.5mg twice daily oral dose.
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Investigators

  • Principal Investigator: Naveen Seecheran, The University of The west Indies, Saint Augustine, Trinidad and Tobago.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Actual)

October 20, 2024

Study Completion (Actual)

November 4, 2024

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC-SA2525/02/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are available from the corresponding author on request.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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