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

  • STATUS
    Recruiting
  • days left to enroll
    45
  • participants needed
    99
  • sponsor
    Arena Pharmaceuticals
Updated on 21 July 2022

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).

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.

Details
Condition Microvascular Obstruction
Treatment Placebo, Temanogrel
Clinical Study IdentifierNCT04848220
SponsorArena Pharmaceuticals
Last Modified on21 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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