Status:
TERMINATED
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Arena is a wholly owned subsidiary of Pfizer
Conditions:
Microvascular Obstruction
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief 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 in...
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 plann...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04848220
Start Date
May 20 2021
End Date
August 31 2022
Last Update
December 12 2023
Active Locations (12)
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1
Tibor Rubin VA Medical Center
Long Beach, California, United States, 90822-5201
2
VA Palo Alto - Cardiac Catheterization Laboratory
Palo Alto, California, United States, 94304
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050