Overview

Trimetazidine as an Adjunct to Enhance Clopidogrel Response.

Status:
Completed

Trial end date:
2019-04-01

Target enrollment:
0

Participant gender:
All

Summary

Hypothesis: Trimetazidine improves Clopidogrel response in patients. • The investigators postulate that the inhibition of platelet aggregation in response to Clopidogrel may be accentuated by Trimetazidine, i.e. Trimetazidine enhances Clopidogrel response. Null Hypothesis: There is no difference in Clopidogrel response in patients with stable coronary artery disease with adjunctive Trimetazidine.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The University of The West Indies

Treatments:

Clopidogrel
Ticlopidine
Trimetazidine

Criteria

Inclusion Criteria:

1. between 18 and 74 years of age,

2. have stable coronary artery disease, already on DAPT with aspirin and clopidogrel for
at least 6 months,

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.