EUCTR2012-000632-26-IT进行中（未招募）不适用
Effect of BivaliRudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3) - BRAVO 2/3
THE MEDICINES COMPANY UK0 个研究点目标入组 526 人开始时间: 2012年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 526
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
- •All patients =18 years of age who are deemed appropriate candidates at high surgical risk(Euroscore =18,or considered inoperable)undergoing TAVR via transfemoral arterial access, that have provided written informed consent before initiation of any study related procedures
- •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 186
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 434
排除标准
- •1. Contraindication to bivalirudin or UFH 2. Refusal to receive blood transfusion 3. Mechanical valve (any location) or mitral bioprosthetic valve 4. Extensive calcification of the common femoral artery, or minimal luminal diameter<6.5 mm 5. Use of elective surgical cut-down for transfemoral access 6. Concurrent performance of percutaneous coronary intervention with TAVR 7. International normalized ratio (INR) = 2 on the day of TAVR procedure, or known history of bleeding diathesis 8. History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation 9. Severe left ventricular dysfunction (left ventricular ejection fraction<15%) 10. Severe aortic regurgitation or mitral regurgitation (4+) 11. Hemodynamic instability (e.g. requiring inotropic or IABP support) within 2 hours of the procedure 12. dialysis dependent 13. Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure 14. Acute myocardial infarction, major surgery or any Therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days 15. Percutaneous coronary intervention within 30 days 16. Upper gastrointestinal or genitourinary bleed within 30 days 17. Stroke or transient ischemic attack within 30 days 18. Any surgery or biopsy within 2 weeks 19. Administration of: a. UFH within 30 minutes of the procedure b. Enoxaparin within 8 hours of the procedure c. Fondaparinux or other LMWHs within 24 hours of the procedure d. Dabigatran, rivaroxaban or other oral anti-Xa or antithrombin agent within 48 hours of the procedure e. Thrombolytics, GPI, or warfarin within 72 hours of the procedure 20. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast 21. Contraindications or allergy to aspirin or clopidogrel 22. Known or suspected pregnant women, or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy. 23. Previous enrolment in this study 24. Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
研究者
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