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A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary Intervention

NCT04848220•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether intravenous temanogrel is a safe and effective treatment for microvascular obstruction (MVO) in adult participants undergoing percutaneous coronary intervention (PCI).

Detailed Description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to be conducted in 2 stages (Stage A and Stage B). Stage A is an ascending single-dose placebo-controlled study planned to consist of 2 cohorts. Stage B is a parallel-treatment group study planned to consist of a placebo group and 2 active treatment groups of temanogrel doses selected based on safety and tolerability data in Stage A.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Stable angina participants suitable for elective PCI, or participants suitable for PCI for diagnosis of non-ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) who are consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction (TIMI) Flow Grade 2 or 3 on the diagnostic angiography
•Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography and must satisfy the study criteria regarding lesion size and vessel diameter/type.
•Females must not be of childbearing potential
•Males with pregnant or non-pregnant female partners of childbearing potential must agree to using a condom during treatment and for 90 days following treatment

Exclusion Criteria

•Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies during the PCI procedure
•Any history of stroke, seizure, intracranial bleeding, or intracranial aneurysm
•Transient ischemic attack within the 6 months prior to Screening
•History of major trauma, major surgery, and/or clinically significant head injury or hemorrhage within the last 6 months of Screening
•Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI within the target vessel territory within the last 4 months of Screening

Locations (12)

Tibor Rubin VA Medical Center

Long Beach, California, United States

VA Palo Alto - Cardiac Catheterization Laboratory

Palo Alto, California, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Alfred Health - The Alfred Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Maasstad Hospital

Rotterdam, South Holland, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Key Dates

Start Date

May 20, 2021

Primary Completion Date

August 23, 2022

Completion Date

August 31, 2022

Last Updated

December 12, 2023

Enrollment

ACTUAL participants

Conditions

Microvascular Obstruction

Interventions

Temanogrel

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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