Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin - Full Text View

Purpose

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	Intervention	Phase
Thromboembolism Bleeding	Drug: Aspirin Drug: Warfarin	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Blood Thinners

Drug Information available for: Aspirin Salicylic acid Warfarin Warfarin sodium

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Haemorrhagic complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Bleeding complications
Thromboembolic complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Registration of surgical data and postoperative complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]


Enrollment:	370
Study Start Date:	June 2005
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	60 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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


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
Study First Received:	September 22, 2009
Last Updated:	August 4, 2014
Health Authority:	Denmark: Ethics Committee

Keywords provided by 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 Anticoagulants Warfarin Aspirin 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

ClinicalTrials.gov processed this record on September 30, 2016