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Thromboxane Receptor Antagonist to Improve Endothelial Function

NCT ID: NCT03962855

Last Updated: 2024-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2022-11-15

Brief Summary

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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

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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

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Cardiovascular Diseases Vascular Dilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center, prospectively randomized, double-blinded, placebo-controlled clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ifetroban

Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.

Group Type ACTIVE_COMPARATOR

Ifetroban Sodium

Intervention Type DRUG

Ifetroban sodium 250 mg capsule once daily for 4 weeks

Placebo

Matching placebo administered once daily for a minimum of 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo arm to match Ifetroban Sodium once daily for 4 weeks.

Interventions

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Ifetroban Sodium

Ifetroban sodium 250 mg capsule once daily for 4 weeks

Intervention Type DRUG

Placebo

Placebo arm to match Ifetroban Sodium once daily for 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Jeffrey Rade

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Rade

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeffrey J Rade, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UMMS-TPRA-01

Identifier Type: -

Identifier Source: org_study_id