EUCTR2020-000238-16-NL进行中（未招募）1 期
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.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Stable angina patients referred for elective percutaneous coronary intervention (PCI), or non-ST-elevation myocardial infarction (NSTEMI) and unstable angina (UA) patients undergoing PCI at least 12 hours after diagnosis for NSTEMI/UA. NSTEMI/UA patients are to be consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction Grade 3 on the diagnostic angiography prior to PCI
- •- Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography prior to PCI. The lesion must be located in a =2.75 millimeter (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. 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
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •- Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies during the PCI procedure;
- •- Any history of stroke, head injury, 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 hemorrhage within the last 6 months of Screening;
- •- NSTEMI/UA with subsequent cardiac troponin levels that are increasing (not stable or dropping) as shown by the 2 most recent measures after diagnosis of NSTEMI/UA and prior to randomization;
- •- 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.
研究者
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