The Thromboxane Receptor Antagonist to Blunt the Effects of Non-Platelet Thromboxane Generation and Improve Endothelial Cell Function (TRAP) Trial

UMMS-TPRA-01

This study evaluates whether addition of the thromboxane receptor antagonist to chronic aspirin therapy improves endothelial function and reduces non-platelet thromboxane generation in patients with established cardiovascular disease. Half of participants will receive ifetroban and the other half will receive matchcing placebo for the 4 week study period.

2019-09-20

2022-11-07

2024-06-01

Active (not recruiting)

Early phase I

52

Inclusion Criteria: * Males and females ≥18 years of age with established cardiovascular disease * Take 81 mg daily of aspirin as part of their daily medical regimen * Urine thromboxane B2 metabolites \>1500 pg/mg creatinine on screening. * Able to provide written consent and comply with protocol-specific procedures. Exclusion Criteria: * Chronic oral anticoagulation. * ST segment myocardial infarction within 1 month. * Cardiac surgery within 1 month. * Ongoing uncontrolled severe inflammatory condition. * Pregnant or lactating. * Ifetroban or aspirin sensitivity * Inability to perform vascular testing.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single center, prospectively randomized, double-blinded, placebo-controlled clinical trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}

2024-01-11