Effect of BivaliRudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3) - BRAVO 2/3

THE MEDICINES COMPANY UK0 sites526 target enrollmentOctober 16, 2012

ConditionsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Patients undergoing transcatheter aortic valve replacement (TAVR) procedures performed via the transfemoral approach MedDRA version: 14.1Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders

DrugsAngiox

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Sponsor: THE MEDICINES COMPANY UK
Enrollment: 526
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 16, 2012

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

THE MEDICINES COMPANY UK

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.