EUCTR2012-003515-58-PT进行中（未招募）1 期
GLOBAL LEADERS: Comparative effectiveness of 1 month of ticagrelor plus aspirin followed by ticagrelor monotherapy versus a current-day intensive dual antiplatelet therapy in all-comers patients undergoing percutaneous coronary intervention with bivalirudin and BioMatrix family drug-eluting stent use. - GLOBAL LEADERS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ECRI
- 入组人数
- 16,000
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
- •Real world, all comer” patients
- •1. Age =18 years;
- •2.Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation in a vessel with a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, and vessels, and lesion length).
- •3. Able to provide informed consent and willing to participate in 2 year follow-up period.
- •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 10000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6000
排除标准
- •1.Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
- •2.Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
- •3.Known moderate to severe hepatic impairment (alanine-aminotransferase = 3 x ULN);
- •4.Planned surgery, including CABG as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
- •5.Need for chronic oral anti-coagulation therapy;
- •6.Active major bleeding or major surgery within the last 30 days;
- •7.Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
- •8.Known stroke (any type) within the last 30 days;
- •9.Known pregnancy at time of randomisation;
- •10. Female who is breastfeeding at time of randomisation;
- •11. Currently participating in another trial and not yet at its primary endpoint.
研究者
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