Trimetazidine as an Adjunct to Enhance Clopidogrel Response.

NCT03603249 | Completed Phase 2

• 1 other identifier: CEC170/04/16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet Dysfunction Due to Drugs

Keywords

platelet inhibition; platelet reactivity; clopidogrel; trimetazidine

Outcome Measures

Primary Outcomes (1)

• Change in Platelet Reactivity Units at baseline compared to post-intervention with Trimetazidine

  The investigators postulate that inhibition of platelet aggregation in response to Clopidogrel may be accentuated by Trimetazidine, i.e. Trimetazidine enhances Clopidogrel response.

  10-14 days

Study Arms (1)

Clopidogrel and Trimetazidine Arm

EXPERIMENTAL

Patients on DAPT for at least 6 months will be tested for platelet function testing with the P2Y12 VerifyNow assay at baseline. The patients will then undergo at least a 2-week course of Trimetazidine 35 mg/q12h, followed thereafter by platelet function testing.

Drug: Trimetazidine

Interventions

Trimetazidine DRUG

Trimetazidine is a clinically effective antianginal agent that has no negative inotropic or vasodilator properties (6). It is presently clinically used throughout Europe and in \>80 countries worldwide. It is a cytoprotective drug that normalizes metabolic disturbances in low-flow ischemia via several-not yet fully understood-mechanisms of action (7). The best-known mechanism of action is its capacity to inhibit β-oxidation of free fatty acid (FFA) (7).

Also known as: Vasteral MR, Laboratoires Servier, France

Clopidogrel and Trimetazidine Arm

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 74 years of age,
• have stable coronary artery disease, already on DAPT with aspirin and clopidogrel for at least 6 months,
• not on any physician-prescribed medications or complementary/alternative therapies,

You may not qualify if:

• presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
• history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
• clinical and/or hemodynamic instability,
• within 1 month of placement of a bare metal stent,
• within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
• planned coronary revascularization,
• treatment with fibrin-specific fibrinolytic therapy \<24 h or non-fibrin-specific fibrinolytic therapy \<48 h,
• use of an oral anticoagulation agent or international normalized ratio \>1.5,
• body weight \<60 kg,
• age \>75 years,
• hemoglobin \<10 g/dL,
• platelet count \<100×106/μL,
• creatinine \>2 mg/dL,
• hepatic enzymes \>2.5 times the upper limit of normal,
• pregnancy and/or lactation.

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

The University of the West Indies

Saint Augustine, North, 000000, Trinidad and Tobago

Location

Related Publications (1)

• Seecheran N, Seebalack V, Seecheran R, Maharaj A, Boodhai B, Seecheran V, Persad S, Motilal S, Tello-Montoliu A, Schneider D. TRimetazidine as an Agent to affeCt clopidogrEl Response: The TRACER Study. Cardiol Ther. 2019;8(2):229-237. doi: 10.1007/s40119-019-0139-0. Epub 2019 Jul 10.

  PMID: 31292901 DERIVED

MeSH Terms

Interventions

Trimetazidine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: The Outcomes Assessor will be independent of the Clinical Research Associates, i.e. he/she will be analyzing the VerifyNow samples without knowledge of the intervention the patient has received.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be of a prospective, randomized, controlled, sequential trial design.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: July 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 2, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Throughout the entire study duration.
• Access Criteria: Unrestricted

Locations

TR (1)