Phase 2
Completed N=57
Thromboxane Receptor Antagonist to Improve Endothelial Function
Cardiovascular Disease · Vascular Dilation
Source: ClinicalTrials.gov NCT03962855 ↗
Enrolled (actual)
57
Serious AEs
5.3%
Results posted
Dec 2024
Primary outcomePrimary: Change in Reactive Hyperemia Index (RHI) — -0.01; 0.21 percentage index change
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.
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 | — |
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.
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. Informational only — not medical advice.