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Trial record 72 of 293 for:    warfarin AND anticoagulation

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

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE October 17, 2011
Last Update Posted Date August 5, 2014
Study Start Date  ICMJE June 2005
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
  • Haemorrhagic complications due to anticoagulant therapy and treatment with Aspirin [ Time Frame: 2006 - 2011 (5 years) ]
  • Thromboembolic complications due to anticoagulant therapy and treatment with Aspirin [ Time Frame: 2006-2011 (5 years) ]
Change History Complete list of historical versions of study NCT01452568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
  • Echocardiographic findings before surgery, before discharge and 3 months after implantation [ Time Frame: 2006 - 2011 (5 years) ]
  • Registration of surgical data and postoperative complications [ Time Frame: 2006-2011 (5 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
Official Title  ICMJE Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thromboembolism
  • Bleeding
Intervention  ICMJE
  • Drug: Aspirin
    150mg/daily for three months, starting day after surgery
    Other Name: Magnyl, Acetyl salicylic acid
  • 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
Study Arms  ICMJE
  • Experimental: Aspirin
    Aspirin 150mg daily, starting day 1 after surgery, for three months.
    Intervention: Drug: Aspirin
  • Active Comparator: Warfarin
    Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
    Intervention: Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2013)
370
Original Actual Enrollment  ICMJE
 (submitted: October 14, 2011)
600
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01452568
Other Study ID Numbers  ICMJE 01-080/04
(KF) 01-080/04 ( Other Identifier: Science Ethics Committee Copenhagen )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nikolaj B. Lilleoer, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Rigshospitalet, Denmark
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP