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Clinical Trials/NL-OMON51876
NL-OMON51876
Completed
Phase 2

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 - APD791202

Arena Pharmaceuticals, Inc.0 sites27 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Arena Pharmaceuticals, Inc.
Enrollment
27
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial ended prematurely

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Stable angina patients suitable for elective PCI or patients suitable for PCI
  • •for diagnosis of NSTEMI/UA. NSTEMI/UA patients are to be 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. Acceptable lesions cannot be in the left main artery or
  • •in a vein or arterial graft, or be a chronic total occlusion or in\-stent
  • •restenosis. Two or more sequential lesions may be treated in the same artery,
  • •as long as they are treated in the same session and at least one of the lesions
  • •meets inclusion criteria:

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
  • •\- 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 6 months of Screening
  • •(eg, a patient with a NSTEMI because of a lesion in a diagonal may not be
  • •included if there is a history of anterior STEMI due to left anterior

Outcomes

Primary Outcomes

Not specified

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