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 个研究点目标入组 27 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

Trial ended prematurely

•- 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:
•For elective PCI patients and non-urgent NSTEMI/UA patients (PCI >12 hours
•after diagnosis), the lesion must be located in a >= 2.75 mm diameter coronary
•artery; the lesion must also be >= 18 mm long and require the use of one or more
•stents that in total must be >= 20 mm long.
•For NSTEMI patients treated with PCI urgently (within 12 hours after
•diagnosis), the coronary artery diameter of the culprit lesion must be >= 2.75
•- Both men and women participants agree to use a highly effective method of
•birth control throughout the entire study period, from informed consent through
•the adverse
•event reporting period, if the possibility of conception exists

•- 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
•descending artery lesion that occurred within the last 6 months);
•- Known history of heart failure with reduced ejection fraction (HFrEF) defined
•ventricular ejection fraction <= 40% prior to current hospital admission.

发起方