Investigating Aspirin Resistance in Trinidad

Aspirin Resistance in Trinidad: The ART Pilot Study.

This study is trying to see if some healthy people have a reduced response to aspirin and how well it works to prevent blood clots.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: The University of The West Indies (Academic / other)
• Locations: 1 site (Saint Augustine, North)
• Trial ID: NCT06228820 on ClinicalTrials.gov

What this trial studies

This study aims to explore the phenomenon of aspirin resistance, where some patients do not respond adequately to aspirin therapy, despite its known benefits in reducing vascular disease risk. Participants will be healthy individuals aged 18 to 74, who are not on any medications, to assess the efficacy of aspirin in inhibiting platelet function. The study will involve administering 81 mg of aspirin and monitoring platelet aggregation responses to determine the prevalence of resistance. Accurate laboratory assays will be utilized to evaluate the effectiveness of aspirin therapy in these participants.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 74 who are not taking any medications.

Not a fit: Patients with a history of bleeding disorders, recent surgeries, or those on anticoagulants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of aspirin resistance, enhancing treatment outcomes for patients at risk of cardiovascular events.

How similar studies have performed: While aspirin resistance has been studied previously, this specific approach focusing on a healthy population in Trinidad is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. between 18 and 74 years of age,
2. healthy with no overt medical conditions,
3. not on any physician-prescribed medications or complementary/alternative therapies,

Exclusion Criteria:

1. presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
2. history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
3. clinical and/or hemodynamic instability,
4. within 1 month of placement of a bare metal stent,
5. within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
6. planned coronary revascularization,
7. treatment with fibrin-specific fibrinolytic therapy \<24 h or non-fibrin-specific fibrinolytic therapy \<48 h,
8. use of an oral anticoagulation agent or international normalized ratio \>1.5,
9. body weight \<60 kg,
10. age \>75 years,
11. hemoglobin \<10 g/dL,
12. platelet count \<100×106/μL,
13. creatinine \>2 mg/dL,
14. hepatic enzymes \>2.5 times the upper limit of normal,
15. pregnancy and/or lactation,
16. the patient is on any other antithrombotic therapies such as ticagrelor, dabigatran, rivaroxaban and apixaban

Where this trial is running

Saint Augustine, North

• The University of the West Indies — Saint Augustine, North, Trinidad and Tobago (Recruiting)

Study contacts

• Study coordinator: Naveen A Seecheran, MBBS, MSc

Conditions Platelet Dysfunction Due to Drugs; Aspirin