Status:
UNKNOWN
PERIOP 2 - A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin.
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Pfizer
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine the effectiveness and safety of LMWH postoperative bridging therapy (standard of care) versus postoperative placebo bridging therapy (experimental arm)for pati...
Detailed Description
There are a growing number of patients who receive long-term warfarin therapy for the prevention of arterial thromboembolism. The current approach to the perioperative management of anticoagulation (i...
Eligibility Criteria
Inclusion
- Informed consent,
- Patients aged \>18
- Patients with prosthetic(mechanical) heart valve
- Patients with atrial fibrillation or atrial flutter and a major risk factor (previous TIA or stroke, high blood pressure, diabetes, aged \>75, moderate/severe left ventricle dysfunction)
- Who are receiving long-term oral anticoagulation and require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.
Exclusion
- Evidence of active bleeding within last 30 days prior to stopping warfarin.
- Platelet count \<100 x 109/L.
- Spinal or neurosurgery.
- Life expectancy less than 3 months.
- Calculated creatinine clearance \<30 ml/min
- Patients requiring cardiac surgery.
- Multiple prosthetic(mechanical) valves or Starr-Edwards valve or prosthetic(mechanical) valve with a history of stroke or TIA
- History of heparin induced thrombocytopenia (HIT)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
1473 Patients enrolled
Trial Details
Trial ID
NCT00432796
Start Date
December 1 2006
End Date
December 1 2020
Last Update
February 19 2020
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
2
Hamilton Health Sciences Corporation-General Hospital
Hamilton, Ontario, Canada, L8L 2X2
3
Hamilton Health Sciences Corporation-McMaster Site
Hamilton, Ontario, Canada, L8N 3Z5
4
Hamilton Health Sciences Corporation-Henderson Site
Hamilton, Ontario, Canada, L8V 1C3