Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Bleeding Clinical Trial

Official title:

Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452568
• Other study ID #: 01-080/04
• Secondary ID: (KF) 01-080/04
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2009
• Last updated: August 4, 2014
• Start date: June 2005
• Est. completion date: March 2012

Study information

• Verified date: August 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Thromboembolism

Intervention

Drug:
• Aspirin
150mg/daily for three months, starting day after surgery
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemorrhagic complications	Bleeding complications	3 months	Yes
Primary	Thromboembolic complications	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.	3 months	Yes
Secondary	Echocardiographic findings before surgery, before discharge and 3 months after implantation		3 months	No
Secondary	Registration of surgical data and postoperative complications		3 months	No
Secondary	All cause mortality		3 months	Yes