CompletedPhase 2

Thromboxane Receptor Antagonist to Improve Endothelial Function

United States57 participantsStarted 2019-09-20

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Reactive Hyperemia Index (RHI)

Timeframe: Baseline to 4 weeks

Trial details

NCT IDNCT03962855

SponsorJeffrey Rade

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-07

Results submitted2024-09-30

View on ClinicalTrials.gov More Cardiovascular Diseases trials