Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thromboembolism Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin

Aspirin 150mg daily, starting day 1 after surgery, for three months.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

150mg/daily for three months, starting day after surgery

Warfarin

Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.

Interventions

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Aspirin

150mg/daily for three months, starting day after surgery

Intervention Type DRUG

Warfarin

Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.

Intervention Type DRUG

Other Intervention Names

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Magnyl, Acetyl salicylic acid marevan

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes