EUCTR2012-003515-58-BE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.Currently participating in another trial and not yet at its primary endpoint.
研究者
相似试验
已完成
3 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.coronair artery disease10011082angina pectorisNL-OMON44752ECRI / Cardialysis1,800
进行中（未招募）
1 期
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.Subjects either male or female eligible for percutaneous coronary intervention (PCI) with lesions suitable for stent implantation who meet all eligibility criteria and provide written informed consent will be included. Of note, inclusion criteria will be kept comprehensive to reflect routine clinical practice (i.e. real world, all-comers” patients).MedDRA version: 17.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersEUCTR2012-003515-58-PTECRI16,000
进行中（未招募）
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Comparative effectiveness of 1 month of ticagrelor plus aspirin followed by ticagrelor on its own versus a current-day intensive antiplatelet therapy with 2 antiplatelet drugs in patients who are having a stent inserted into their coronary artery.Subjects either male or female eligible for percutaneous coronary intervention (PCI) with lesions suitable for stent implantation who meet all eligibility criteria and provide written informed consent will be included. Of note, inclusion criteria will be kept comprehensive to reflect routine clinical practice (i.e. real world, all-comers” patients).MedDRA version: 19.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersEUCTR2012-003515-58-GBEuropean Cardiovascular Research Institute16,000
进行中（未招募）
1 期
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.Subjects either male or female eligible for percutaneous coronary intervention (PCI) with lesions suitable for stent implantation who meet all eligibility criteria and provide written informed consent will be included. Of note, inclusion criteria will be kept comprehensive to reflect routine clinical practice (i.e. ?real world, all-comers? patients).MedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersEUCTR2012-003515-58-ESECRI16,000
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