Status:
COMPLETED
Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Thromboembolism
Bleeding
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial. The aim of this trial was to compare warfarin therapy (t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery.
- Age 60 years Sinus rhythm
- Exclusion Criteria:
- Patients planned for double valve surgery
- Patients with active endocarditis
- Patients with atrial fibrillation/flutter
- Patients in anticoagulation treatment of other reason.
- Patients with previous cerebrovascular accidents or insults.
- Patients with TCI
- Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable
- Patients with pacemaker
- Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer
- Patients that is HIV-positive or have active AIDS
- Patients that are known drug abuser
- Patients in chronic haemodialysis or other types of dialysis
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT01452568
Start Date
June 1 2005
End Date
March 1 2012
Last Update
August 5 2014
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