Clinical trial NCT01452568: Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
Official title: Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thromboembolism
Bleeding
Keywords: Thromboembolic complications
Bleeding complications
Haemorrhagic complications
Anticoagulant therapy
Aspirin
biological Aorta Valve
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 370
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.


Eligibility criteria: 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

Primary outcomes:
measure: Haemorrhagic complications
timeFrame: 3 months
measure: Thromboembolic complications
timeFrame: 3 months
Secondary outcomes:
measure: Echocardiographic findings before surgery, before discharge and 3 months after implantation
timeFrame: 3 months
measure: Registration of surgical data and postoperative complications
timeFrame: 3 months
measure: All cause mortality
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
name: Peter S Olsen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
name: Nikolaj B Lilleør
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
name: Sulman Rafiq
role: STUDY_CHAIR
References: