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

NCT06567678 | Completed Phase 1 FDA Drug

• 1 other identifier: CREC-SA2525/02/2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• P2Y12 reaction units and Aspirin reaction units

  P2Y12 and Aspirin reaction units pre and post colchicine 0.5mg twice daily oral dose.

  two weeks

Study Arms (1)

Colchicine 0.5mg po bd

EXPERIMENTAL

Patients with coronary disease taking Colchicine 0.5mg twice-daily orally for two weeks

Drug: Colchicine 0.5 MG oral tablet twice daily

Interventions

Colchicine 0.5 MG oral tablet twice daily DRUG

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

Colchicine 0.5mg po bd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients already on colchicine

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

The University of The West Indies

Saint Augustine, Trinidad and Tobago

Location

Related Publications (1)

• Seecheran N, Grimaldos K, McCallum P, Ramcharan P, Kawall J, Katwaroo A, Grimaldos G, Seecheran V, Jagdeo CL, Rafeeq S, Seecheran R, Leyva Quert A, Ali N, Peram L, Motilal S, Ramtahal R, Bhagwandass N, Giddings S, Ramlackhansingh A, Sandy S. The Effect of Colchicine on Platelet Function Profiles in Patients with Stable Coronary Artery Disease: The ECLIPSE Pilot Study. Cardiol Ther. 2025 Mar;14(1):87-100. doi: 10.1007/s40119-024-00393-2. Epub 2025 Jan 18.

  PMID: 39826082 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Naveen Seecheran

  The University of The west Indies, Saint Augustine, Trinidad and Tobago.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: August 21, 2024
• Primary Completion: October 20, 2024
• Study Completion: November 4, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TR (1)