EUCTR2012-000632-26-DE进行中（未招募）1 期
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 - BRAVO 2/3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 870
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
- •Patients may be included in the study if they meet all of the following criteria:
- •1. = 18 years of age
- •2. High risk (Euroscore =18, or considered inoperable) for surgical aortic valve replacement
- •3. Undergoing TAVR via transfemoral arterial access
- •4. Provide written informed consent before initiation of any study related procedures
- •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 261
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 609
排除标准
- •Patients will be excluded from the study if any of the following exclusion criteria apply prior to enrollment:
- •1. Any known contraindication to the use of bivalirudin (except presence of severe renal impairment [GFR<30 ml/min] since these patients will be included in the trial - please see protocol section 8.1.1) 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
- •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
相似试验
已完成
3 期
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3severe aortic stenosissevere narrowing of a aorta valve10046973NL-OMON39580Medicines Company60
进行中（未招募）
1 期
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3EUCTR2012-000632-26-NLThe Medicines Company803
进行中（未招募）
1 期
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3Patients undergoing transcatheter aortic valve replacement (TAVR) procedures performed via the transfemoral approach.MedDRA version: 17.0 Level: PT Classification code 10002916 Term: Aortic valve replacement System Organ Class: 10042613 - Surgical and medical proceduresEUCTR2012-000632-26-GBThe Medicines Company803
进行中（未招募）
不适用
Effect of BivaliRudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)Patients undergoing transcatheter aortic valve replacement (TAVR) procedures performed via the transfemoral approachMedDRA version: 14.1Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersEUCTR2012-000632-26-ITTHE MEDICINES COMPANY UK526
已完成
3 期
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFHSevere Aortic StenosisTranscatheter Aortic Valve ReplacementAortic Valve ReplacementNCT01651780The Medicines Company803