Thromboxane Receptor Antagonist to Improve Endothelial Cell Function

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeffrey Rade
• Collaborators: American Heart Association; Cumberland Pharmaceuticals
• Treatments: Ifetroban

Criteria

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.