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Ifetroban for Vasodilation (TRAP Trial)

Phase 2
Waitlist Available
Led By Jeffrey J Rade, MD
Research Sponsored by Jeffrey Rade
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Take 81 mg daily of aspirin as part of their daily medical regimen
Males and females ≥18 years of age with established cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights

TRAP Trial Summary

This trial will test if adding a thromboxane receptor antagonist to aspirin therapy can improve endothelial function and reduce non-platelet thromboxane generation in patients with cardiovascular disease.

Who is the study for?
This trial is for men and women over 18 with cardiovascular disease who are already taking low-dose aspirin. They must have certain levels of a urine marker indicating thromboxane activity and be able to follow the study rules. People can't join if they're on long-term blood thinners, had recent heart surgery or a severe heart attack, are pregnant or breastfeeding, can't do vascular tests, or have uncontrolled inflammation or allergies to the study drugs.Check my eligibility
What is being tested?
The trial is testing Ifetroban Sodium against a placebo in patients with cardiovascular issues who take aspirin. The goal is to see if Ifetroban improves blood vessel function and lowers non-platelet thromboxane production. Participants will either get Ifetroban or a dummy pill for four weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally speaking, participants may experience reactions related to altering platelet function such as bleeding complications, gastrointestinal symptoms like stomach pain or ulcers due to aspirin use alongside the trial medication.

TRAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I take 81 mg of aspirin daily for my health.
Select...
I am 18 or older with a diagnosed heart condition.

TRAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peripheral Arterial Tonometry
Secondary outcome measures
Brachial vasoractivity
Non-platelet thromboxane generation
Other outcome measures
Cardiac Function
Coagulation Markers
Inflammatory Markers
+4 more

TRAP Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IfetrobanActive Control1 Intervention
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo administered once daily for a minimum of 4 weeks.

Find a Location

Who is running the clinical trial?

Jeffrey RadeLead Sponsor
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,778 Total Patients Enrolled
1 Trials studying Vasodilation
35 Patients Enrolled for Vasodilation
Cumberland PharmaceuticalsIndustry Sponsor
62 Previous Clinical Trials
9,411 Total Patients Enrolled

Media Library

Ifetroban Clinical Trial Eligibility Overview. Trial Name: NCT03962855 — Phase 2
Vasodilation Research Study Groups: Placebo, Ifetroban
Vasodilation Clinical Trial 2023: Ifetroban Highlights & Side Effects. Trial Name: NCT03962855 — Phase 2
Ifetroban 2023 Treatment Timeline for Medical Study. Trial Name: NCT03962855 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Thromboxane Receptor Antagonist to Improve Endothelial Cell Function
Jeffrey Rade 2019. "Thromboxane Receptor Antagonist to Improve Endothelial Cell Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03962855.
~9 spots leftby Apr 2025
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