A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Microvascular Obstruction
In brief
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).
Key facts
- Study ID
- NCT04848220
- Run by
- Pfizer
- People needed
- 29
- Starts
- 2021-05-20
- Expected to finish
- 2022-08-31
- Last updated by the study team
- 2023-12-12
Who can join
Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Skåne University Hospital — Lund, Sweden
- East and North Hertfordshire NHS Trust Lister Hospital — Stevenage, United Kingdom
Full record on ClinicalTrials.gov
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