Thromboxane Receptor Antagonist to Improve Endothelial Function

NCT03962855 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UMMS-TPRA-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Vascular Dilation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 4 weeks

Secondary Outcomes (2)

• Change in Percent Flow-mediated Vasodilation (FMD)

  Baseline to 4 weeks

• Change in Urinary TXB2-M

  Baseline to 4 weeks

Study Arms (2)

Ifetroban

ACTIVE COMPARATOR

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

Drug: Ifetroban Sodium

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ifetroban Sodium DRUG

Ifetroban sodium 250 mg capsule once daily for 4 weeks

Ifetroban

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeffrey Rade: lead
• American Heart Association: collaborator
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Jeffrey J Rade MD
• Organization: University of Massachusetts Medical School

jeffrey.rade@umassmed.edu

774-441-6310

Study Officials

• Jeffrey J Rade, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single center, prospectively randomized, double-blinded, placebo-controlled clinical trial.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 24, 2019
• Study Start: September 20, 2019
• Primary Completion: November 7, 2022
• Study Completion: November 15, 2022
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)