Phase 2 N=57 Randomized Quadruple-blind Treatment

Thromboxane Receptor Antagonist to Improve Endothelial Function

Cardiovascular Diseases · Vascular Dilation

Bottom Line

View on ClinicalTrials.gov: NCT03962855 ↗

Enrolled (actual)

Serious AEs

5.3%

Results posted

Dec 2024

Primary outcome: Primary: Change in Reactive Hyperemia Index (RHI) — -0.01; 0.21 percentage index change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ifetroban Sodium (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jeffrey Rade
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Reactive Hyperemia Index (RHI)	-0.01; 0.21	—
SECONDARY Change in Percent Flow-mediated Vasodilation (FMD)	11.36; -15.83	—
SECONDARY Change in Urinary TXB2-M	370.7; -210.9	—

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.

Eligibility Criteria

Inclusion Criteria

Males and females 18-80 years of age with established cardiovascular disease
Take >=81 mg daily of aspirin as part of their daily medical regimen
Urine thromboxane B2 metabolites >1145 pg/mg creatinine on screening.
Able to provide written consent and comply with protocol-specific procedures.

Exclusion Criteria

Chronic oral anticoagulation with a non-vitamin K antagonist.
Anticipated change or interruption in aspirin therapy during the study period.
ST segment myocardial infarction within the past 30 days.
Cardiac surgery within the past 30 days.
Stage 4-5 renal failure or on renal replacement therapy.
An ongoing uncontrolled severe inflammatory condition.
Pregnant, intending to become pregnant or breast feeding.
Known ifetroban or aspirin sensitivity Inability to perform vascular testing.
Participation in another investigational drug trial within 30 days of randomization.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03962855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.