Back to resultsAnticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
Primary Purpose
Thromboembolism, Bleeding
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aspirin
Warfarin
Sponsored by
About this trial
This is an interventional treatment trial for Thromboembolism focused on measuring Thromboembolic complications, Bleeding complications, Haemorrhagic complications, Anticoagulant therapy, Aspirin, biological Aorta Valve
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aspirin
Warfarin
Arm Description
Aspirin 150mg daily, starting day 1 after surgery, for three months.
Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
Outcomes
Primary Outcome Measures
Haemorrhagic complications
Bleeding complications
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.
Secondary Outcome Measures
Echocardiographic findings before surgery, before discharge and 3 months after implantation
Registration of surgical data and postoperative complications
All cause mortality
Full Information
NCT ID
NCT01452568
First Posted
September 22, 2009
Last Updated
August 4, 2014
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01452568
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Bleeding
Keywords
Thromboembolic complications, Bleeding complications, Haemorrhagic complications, Anticoagulant therapy, Aspirin, biological Aorta Valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Aspirin 150mg daily, starting day 1 after surgery, for three months.
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Magnyl, Acetyl salicylic acid
Intervention Description
150mg/daily for three months, starting day after surgery
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
marevan
Intervention Description
Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.
Primary Outcome Measure Information:
Title
Haemorrhagic complications
Description
Bleeding complications
Time Frame
3 months
Title
Thromboembolic complications
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Echocardiographic findings before surgery, before discharge and 3 months after implantation
Time Frame
3 months
Title
Registration of surgical data and postoperative complications
Time Frame
3 months
Title
All cause mortality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S Olsen, MD, DMSc
Organizational Affiliation
Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikolaj B Lilleør
Organizational Affiliation
Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sulman Rafiq
Organizational Affiliation
Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
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