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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
Sponsor:
Information provided by (Responsible Party):
Nikolaj B. Lilleoer, Rigshospitalet, Denmark

Study Description
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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.


Condition or disease Intervention/treatment Phase
Thromboembolism Bleeding Drug: Aspirin Drug: Warfarin Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Aspirin
Aspirin 150mg daily, starting day 1 after surgery, for three months.
 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Haemorrhagic complications [ Time Frame: 3 months ]
    Bleeding complications

  2. 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.


Secondary Outcome Measures :
  1. Echocardiographic findings before surgery, before discharge and 3 months after implantation [ Time Frame: 3 months ]
  2. Registration of surgical data and postoperative complications [ Time Frame: 3 months ]
  3. All cause mortality [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Keywords provided by Nikolaj B. Lilleoer, Rigshospitalet, Denmark:
Thromboembolic complications
Bleeding complications
Haemorrhagic complications
 Anticoagulant therapy
Aspirin
biological Aorta Valve

Additional relevant MeSH terms:
Hemorrhage
Thromboembolism
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Warfarin
Anticoagulants
Salicylic Acid
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