NCT03962855

Thromboxane Receptor Antagonist to Improve Endothelial Function

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Jeffrey Rade · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 matching placebo for the 4 week study period.

Detailed description

Thromboxane is a prostaglandin produced in healthy individuals mainly in platelets, where it mediates platelet activation and vasoconstriction via binding to cellular thromboxane-prostanoid (TP) receptors. The cardioprotective effect of aspirin is due to suppression of platelet thromboxane generation and reactivity. Unfortunately 25-50% of patients with cardiovascular disease taking ASA continue to generate thromboxane from non-platelet sources, which significantly increases their risk of atherothrombosis and death. Evidence suggests that oxidative stress is a potent stimulus for thromboxane generation in endothelial cells that involves autocrine/paracrine signaling through the TP receptor. This clinical trial addresses the central hypothesis that vascular endothelial cells under oxidative stress are a major source of non-platelet thromboxane generation in patients with cardiovascular disease and that antagonism of the TP receptor will suppress its formation and improve endothelial function.

Conditions

• Cardiovascular Diseases
• Vascular Dilation

Interventions

Type	Name	Description
DRUG	Ifetroban Sodium	Ifetroban sodium 250 mg capsule once daily for 4 weeks
DRUG	Placebo	Placebo arm to match Ifetroban Sodium once daily for 4 weeks.

Timeline

• Start date: 2019-09-20
• Primary completion: 2022-11-07
• Completion: 2022-11-15
• First posted: 2019-05-24
• Last updated: 2024-12-05
• Results posted: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study