EUCTR2013-003201-26-NL进行中（未招募）1 期
A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting - RE-DUAL PCI
Boehringer Ingelheim bv0 个研究点目标入组 2,502 人开始时间: 2014年7月16日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,502
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
- •- Male or female patients aged >=18 years
- •- Patients with Non Valvular Atrial Fibrillation
- •- Patient presenting with:
- •An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent or Drug Eluting Stent)
- •Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)
- •- The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 375
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2127
排除标准
- •- Patients with a mechanical or biological heart valve prosthesis
- •- Cardiogenic shock during current hospitalisation
- •- Stroke within 1 month prior to screening visit
- •- Patients who have had major surgery within the month prior to screening
- •- Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
- •- Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
- •- Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
- •- Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation) <30mL/min at screening
- •- Active liver disease
研究者
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