NCT01452568

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

6.8 years

First QC Date

September 22, 2009

Last Update Submit

August 4, 2014

Conditions

ThromboembolismBleeding

Keywords

Thromboembolic complicationsBleeding complicationsHaemorrhagic complicationsAnticoagulant therapyAspirinbiological Aorta Valve

Outcome Measures

Primary Outcomes (2)

  • Haemorrhagic complications

    Bleeding complications

    3 months

  • Thromboembolic complications

    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.

    3 months

Secondary Outcomes (3)

  • Echocardiographic findings before surgery, before discharge and 3 months after implantation

    3 months

  • Registration of surgical data and postoperative complications

    3 months

  • All cause mortality

    3 months

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin 150mg daily, starting day 1 after surgery, for three months.

Drug: Aspirin

Warfarin

ACTIVE COMPARATOR

Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.

Drug: Warfarin

Interventions

AspirinDRUG

150mg/daily for three months, starting day after surgery

Also known as: Magnyl, Acetyl salicylic acid
Aspirin
WarfarinDRUG

Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.

Also known as: marevan
Warfarin

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ThromboembolismHemorrhage

Interventions

Aspirinaspirin, magnesium oxide combinationWarfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Peter S Olsen, MD, DMSc

    Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Nikolaj B Lilleør

    Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Sulman Rafiq

    Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Project Coordinator

Study Record Dates

First Submitted

September 22, 2009

First Posted

October 17, 2011

Study Start

June 1, 2005

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 5, 2014

Record last verified: 2014-08