Cardiovascular DiseasesPhase 2TRAPNCT03962855
Thromboxane Receptor Antagonist to Improve Endothelial Function
A Phase 2 study testing Ifetroban Sodium in people with Cardiovascular Diseases and Vascular Dilation, run by Jeffrey Rade at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Vascular Dilation
- What is being tested?
- Ifetroban Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 15 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: The Thromboxane Receptor Antagonist to Block the Effects of Non-Platelet Thromboxane Generation and Improve Endothelial Function (TRAP) Trial
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.
Read the 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
- Being tested
- Ifetroban Sodium, Placebo
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifetroban SodiumDrug
Ifetroban sodium 250 mg capsule once daily for 4 weeks
PlaceboDrug
Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ifetroban | Active comparator | Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks. Receives: Drug: Ifetroban Sodium |
| Placebo | Placebo comparator | Matching placebo administered once daily for a minimum of 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reactive Hyperemia Index (RHI)
The change in Reactive Hyperemia Peripheral Index (RHI) as measured by Arterial Tonometry.
The Reactive Hyperemia Index (RHI) is calculated as the ratio of post- to pre-occlusion peripheral arterial tone signals on the occluded side, normalized to the control side, and further adjusted for baseline vascular tone. RHI is automatically measured by the EndoPAT 2000 software. According to the manufacturer, an RHI value greater than 1.67 is considered normal, while a lower value indicates endothelial dysfunction and is associated with an increased risk of cardiovascular events.
Measured: Baseline to 4 weeks
Secondary outcomes (2)
Change in Percent Flow-mediated Vasodilation (FMD)
The measure is the change in flow-mediated vasodilation (FMD) as measured by Brachial vasoractivity
Measured: Baseline to 4 weeks
Change in Urinary TXB2-M
Urinary urinary TXB2-M measured by 11-dhTXB2 ELISA
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start20 Sep 2019
- Primary completion7 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, prospectively randomized, double-blinded, placebo-controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Rade
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Cumberland Pharmaceuticals
- Responsible party
- Sponsor-investigator, Jeffrey Rade, University of Massachusetts, Worcester
- Investigators
- Jeffrey J Rade, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962855
- Sponsor's protocol ID
- UMMS-TPRA-01
- Acronym
- TRAP
- Status last verified
- Nov 2024
- First submitted
- 21 May 2019
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thromboxane Receptor Antagonist to Block the Effects of Non-Platelet Thromboxane Generation and Improve Endothelial Function (TRAP) Trial
- ClinicalTrials.gov ID
- NCT03962855
- Acronym / sponsor ID
- TRAP / UMMS-TPRA-01
- Conditions
- Cardiovascular Diseases, Vascular Dilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Jeffrey RadeUniversity, hospital or other
- Collaborators
- American Heart Association, Cumberland Pharmaceuticals
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, prospectively randomized, double-blinded, placebo-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Ifetroban | Active comparator | Drug: Ifetroban SodiumIfetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered once daily for a minimum of 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifetroban SodiumIfetroban sodium 250 mg capsule once daily for 4 weeks | Drug | Ifetroban |
| PlaceboPlacebo arm to match Ifetroban Sodium once daily for 4 weeks. | Drug | Placebo |
Primary outcome
Change in Reactive Hyperemia Index (RHI)
Time frame: Baseline to 4 weeks
The change in Reactive Hyperemia Peripheral Index (RHI) as measured by Arterial Tonometry. The Reactive Hyperemia Index (RHI) is calculated as the ratio of post- to pre-occlusion peripheral arterial tone signals on the occluded side, normalized to the control side, and further adjusted for baseline vascular tone. RHI is automatically measured by the EndoPAT 2000 software. According to the manufacturer, an RHI value greater than 1.67 is considered normal, while a lower value indicates endothelial dysfunction and is associated with an increased risk of cardiovascular events.
2 secondary outcomes
Change in Percent Flow-mediated Vasodilation (FMD)
Time frame: Baseline to 4 weeks
Change in Urinary TXB2-M
Time frame: Baseline to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Rade, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ifetroban Sodium in people with Cardiovascular Diseases and Vascular Dilation, run by Jeffrey Rade at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reactive Hyperemia Index (RHI) (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.