Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
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ClinicalTrials.gov Identifier: NCT01452568 |
Recruitment Status :
Completed
First Posted : October 17, 2011
Last Update Posted : August 5, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thromboembolism Bleeding | Drug: Aspirin Drug: Warfarin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 370 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Aspirin
Aspirin 150mg daily, starting day 1 after surgery, for three months.
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Drug: Aspirin
150mg/daily for three months, starting day after surgery
Other Name: Magnyl, Acetyl salicylic acid |
Active Comparator: Warfarin
Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
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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.
Other Name: marevan |
- Haemorrhagic complications [ Time Frame: 3 months ]Bleeding complications
- Thromboembolic complications [ Time Frame: 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.
- Echocardiographic findings before surgery, before discharge and 3 months after implantation [ Time Frame: 3 months ]
- Registration of surgical data and postoperative complications [ Time Frame: 3 months ]
- All cause mortality [ Time Frame: 3 months ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452568
Principal Investigator: | Peter S Olsen, MD, DMSc | Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen | |
Principal Investigator: | Nikolaj B Lilleør | Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen | |
Study Chair: | Sulman Rafiq | Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen |
Responsible Party: | Nikolaj B. Lilleoer, Clinical Project Coordinator, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT01452568 History of Changes |
Other Study ID Numbers: |
01-080/04 (KF) 01-080/04 ( Other Identifier: Science Ethics Committee Copenhagen ) |
First Posted: | October 17, 2011 Key Record Dates |
Last Update Posted: | August 5, 2014 |
Last Verified: | August 2014 |
Thromboembolic complications Bleeding complications Haemorrhagic complications |
Anticoagulant therapy Aspirin biological Aorta Valve |
Thromboembolism Hemorrhage Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Aspirin Salicylic Acid Warfarin Anticoagulants Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Anti-Infective Agents Antifungal Agents Keratolytic Agents Dermatologic Agents |