A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intraveno… (NCT04848220) | Clinical Trial Compass
TerminatedPhase 2
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Stopped: Business decision
United States, Australia29 participantsStarted 2021-05-20
Plain-language 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).
Who can participate
Age range30 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)
Timeframe: From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1