Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikolaj B. Lilleoer, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01452568
First received: September 22, 2009
Last updated: August 4, 2014
Last verified: August 2014
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Aspirin
Warfarin
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014