Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Phase 4

Completed

• Conditions: Thromboembolism; Bleeding
• Interventions: Drug: Warfarin; Drug: Aspirin

• Registration Number: NCT01452568
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-17
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warfarin	Warfarin	Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
Aspirin	Aspirin	Aspirin 150mg daily, starting day 1 after surgery, for three months.

Primary Outcome Measures

Name	Time	Method
Haemorrhagic complications	3 months	Bleeding complications
Thromboembolic complications	3 months	TCI, stroke, Myocardial infarction (MI), Pulmonary embolism, Deep vein thrombosis (DVT) , peripheral arterial embolism, intra-cardiac thrombus formation. We expected statistically fewer thromboembolic events in the groups receiving anticoagulation with warfarin than the aspirin only groups.

Secondary Outcome Measures

Name	Time	Method
Echocardiographic findings before surgery, before discharge and 3 months after implantation	3 months
Registration of surgical data and postoperative complications	3 months
All cause mortality	3 months