Coronary Artery DiseasePhase 1ECLIPSENCT06567678
The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease
A Phase 1 study testing Colchicine 0.5 MG oral tablet twice daily in people with Coronary Artery Disease, run by The University of The West Indies at 1 site in Trinidad and Tobago.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Colchicine 0.5 MG oral tablet twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- 21 Aug 2024to 4 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with stable coronary artery disease.
- Patients older than 18 years of age.
- Patients currently on dual anti platelets, aspirin and clopidogrel
Who cannot join
- Patients already on colchicine
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
The University of The West Indies
Saint Augustine
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Colchicine 0.5 MG oral tablet twice daily
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG oral tablet twice dailyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Colchicine 0.5mg po bd | Experimental | Patients with coronary disease taking Colchicine 0.5mg twice-daily orally for two weeks Receives: Drug: Colchicine 0.5 MG oral tablet twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
P2Y12 reaction units and Aspirin reaction units
P2Y12 and Aspirin reaction units pre and post colchicine 0.5mg twice daily oral dose.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start21 Aug 2024
- Primary completion20 Oct 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen Seecheran, The University of The West Indies
- Investigators
- Naveen Seecheran, Principal investigator, The University of The west Indies, Saint Augustine, Trinidad and Tobago.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567678
- Sponsor's protocol ID
- CREC-SA2525/02/2024
- Acronym
- ECLIPSE
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author on request.
Publications
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.
PubMed 39826082
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad and Tobago. The Pilot ECLIPSE Study.
- ClinicalTrials.gov ID
- NCT06567678
- Acronym / sponsor ID
- ECLIPSE / CREC-SA2525/02/2024
- Conditions
- Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colchicine 0.5mg po bd | Experimental | Drug: Colchicine 0.5 MG oral tablet twice dailyPatients with coronary disease taking Colchicine 0.5mg twice-daily orally for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stable coronary artery disease.
- Patients older than 18 years of age.
- Patients currently on dual anti platelets, aspirin and clopidogrel
Key exclusion criteria (1 listed)
- Patients already on colchicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MG oral tablet twice dailyBlood 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 | Drug | Colchicine 0.5mg po bd |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 39826082Seecheran 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.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Seecheran principal investigator
The University of The west Indies, Saint Augustine, Trinidad and Tobago.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colchicine 0.5 MG oral tablet twice daily in people with Coronary Artery Disease, run by The University of The West Indies at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Trinidad and Tobago. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P2Y12 reaction units and Aspirin reaction units (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.