Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 22, 2009
August 4, 2014
June 2005
March 2012   (final data collection date for primary outcome measure)
  • 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.
  • Haemorrhagic complications due to anticoagulant therapy and treatment with Aspirin [ Time Frame: 2006 - 2011 (5 years) ] [ Designated as safety issue: Yes ]
  • Thromboembolic complications due to anticoagulant therapy and treatment with Aspirin [ Time Frame: 2006-2011 (5 years) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01452568 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Echocardiographic findings before surgery, before discharge and 3 months after implantation [ Time Frame: 2006 - 2011 (5 years) ] [ Designated as safety issue: No ]
  • Registration of surgical data and postoperative complications [ Time Frame: 2006-2011 (5 years) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Thromboembolism
  • Bleeding
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01452568
01-080/04, (KF) 01-080/04
No
Nikolaj B. Lilleoer, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
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
Rigshospitalet, Denmark
August 2014

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