PERIOP 2 - A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin.
NCT ID: NCT00432796
Last Updated: 2020-02-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
1473 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-12-31
Study Completion Date
2020-12-31
Brief Summary
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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 patients with mechanical heart valves or atrial fibrillation or atrial flutter who are at high risk for stroke when warfarin is temporarily interrupted for a procedure.
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Detailed Description
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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.e. "bridging therapy") with low molecular weight heparin (LMWH) is not standardized and has not been assessed by adequate randomized studies. Most clinicians, however, recommend bridging therapy.
We have recently completed a multicentre single arm pilot study of LMWH bridging therapy. This study in 10 centres accrued 224 patients in 10 months. In the pilot study the postoperative thromboembolic event rate was 3.1% and 75% of these occurred in patients who had anticoagulation held due to bleeding.
Design:A prospective multicentre randomized double-blind controlled trial. Patients: Consecutive eligible and consenting patients from 11 teaching hospitals in Canada. A total of 1773 patients with prosthetic heart valves receiving long-term oral anticoagulation with warfarin or patients with atrial fibrillation/flutter and a major risk factor who require elective non-cardiac surgery or invasive procedure necessitating reversal of their oral anticoagulant therapy.
Treatment Schedule: Consent will be obtained preoperatively but randomization will be performed postoperatively after confirming eligibility.
Preoperative period: In all participants, warfarin therapy will be discontinued five days prior to the procedure. Dalteparin, a LMWH, will be administered at 200 IU/kg sc early in the morning for the three days prior to, but not including the day of, the procedure except on the day prior to surgery the dose will be 100 I.U./kg given 24 hours preoperatively. Warfarin will be resumed the evening of the procedure.
Postoperative period: Dalteparin or placebo will be administered daily (starting the morning after the procedure), provided surgical hemostasis is achieved, and will be continued for at least four days and until the INR is\>2.0. Patients considered at high risk for a postoperative major bleed will be given dalteparin or placebo at a dose of 5,000 IU sc daily. Patients who undergo procedures that are considered low risk for bleeding complications will resume dalteparin or placebo at 200 IU/Kg s.c. daily.
Outcomes:The primary outcome will be the frequency of episodes of major thromboembolism over a 90-day follow-up period following the time of randomization. Secondary outcomes will include major bleeding and overall survival.
Relevance: To bridge or not to bridge, is a common clinical question, without randomized trial evidence to guide clinicians. This RCT will answer whether post-operative bridging reduces risk of thromboembolism or causes harm.
We have recently completed a multicentre single arm pilot study of LMWH bridging therapy. This study in 10 centres accrued 224 patients in 10 months. In the pilot study the postoperative thromboembolic event rate was 3.1% and 75% of these occurred in patients who had anticoagulation held due to bleeding.
Design:A prospective multicentre randomized double-blind controlled trial. Patients: Consecutive eligible and consenting patients from 11 teaching hospitals in Canada. A total of 1773 patients with prosthetic heart valves receiving long-term oral anticoagulation with warfarin or patients with atrial fibrillation/flutter and a major risk factor who require elective non-cardiac surgery or invasive procedure necessitating reversal of their oral anticoagulant therapy.
Treatment Schedule: Consent will be obtained preoperatively but randomization will be performed postoperatively after confirming eligibility.
Preoperative period: In all participants, warfarin therapy will be discontinued five days prior to the procedure. Dalteparin, a LMWH, will be administered at 200 IU/kg sc early in the morning for the three days prior to, but not including the day of, the procedure except on the day prior to surgery the dose will be 100 I.U./kg given 24 hours preoperatively. Warfarin will be resumed the evening of the procedure.
Postoperative period: Dalteparin or placebo will be administered daily (starting the morning after the procedure), provided surgical hemostasis is achieved, and will be continued for at least four days and until the INR is\>2.0. Patients considered at high risk for a postoperative major bleed will be given dalteparin or placebo at a dose of 5,000 IU sc daily. Patients who undergo procedures that are considered low risk for bleeding complications will resume dalteparin or placebo at 200 IU/Kg s.c. daily.
Outcomes:The primary outcome will be the frequency of episodes of major thromboembolism over a 90-day follow-up period following the time of randomization. Secondary outcomes will include major bleeding and overall survival.
Relevance: To bridge or not to bridge, is a common clinical question, without randomized trial evidence to guide clinicians. This RCT will answer whether post-operative bridging reduces risk of thromboembolism or causes harm.
Conditions
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Stroke
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1
patients are randomized post-operative to receive either active treatment or placebo.
Active treatment is Dalteparin injectable. Patients randomized to active treatment will receive Dalteparin 5,000 iu or 200 iu/kg once daily depending on the type of surgery they have had.
Group Type
ACTIVE_COMPARATOR
Dalteparin
Intervention Type
DRUG
5,000 iu or 200 iu/kg depending on the type of surgery injection will be given subcutaneously, once a day for a minimum of 4 days or until the INR is 2.0
2
patients will be randomized post-operative to receive either active treatment or placebo
Group Type
EXPERIMENTAL
Placebo
Intervention Type
OTHER
patients will be randomized post-operative to receive either active treatment or placebo.
the placebo will be given as a subcutaneous injection once a day. the amount of the placebo will be equivalent to the active treatment depending on the type of surgery.
ie. 5,000 iu or 200 iu/kg
Interventions
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Dalteparin
5,000 iu or 200 iu/kg depending on the type of surgery injection will be given subcutaneously, once a day for a minimum of 4 days or until the INR is 2.0
Intervention Type
DRUG
Placebo
patients will be randomized post-operative to receive either active treatment or placebo.
the placebo will be given as a subcutaneous injection once a day. the amount of the placebo will be equivalent to the active treatment depending on the type of surgery.
ie. 5,000 iu or 200 iu/kg
Intervention Type
OTHER
Other Intervention Names
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Fragmin
Eligibility Criteria
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Inclusion Criteria
1. Informed consent,
2. Patients aged \>18
3. Patients with prosthetic(mechanical) heart valve
4. 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)
5. Who are receiving long-term oral anticoagulation and require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.
2. Patients aged \>18
3. Patients with prosthetic(mechanical) heart valve
4. 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)
5. Who are receiving long-term oral anticoagulation and require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.
Exclusion Criteria
1. Evidence of active bleeding within last 30 days prior to stopping warfarin.
2. Platelet count \<100 x 109/L.
3. Spinal or neurosurgery.
4. Life expectancy less than 3 months.
5. Calculated creatinine clearance \<30 ml/min
6. Patients requiring cardiac surgery.
7. Multiple prosthetic(mechanical) valves or Starr-Edwards valve or prosthetic(mechanical) valve with a history of stroke or TIA
8. History of heparin induced thrombocytopenia (HIT)
2. Platelet count \<100 x 109/L.
3. Spinal or neurosurgery.
4. Life expectancy less than 3 months.
5. Calculated creatinine clearance \<30 ml/min
6. Patients requiring cardiac surgery.
7. Multiple prosthetic(mechanical) valves or Starr-Edwards valve or prosthetic(mechanical) valve with a history of stroke or TIA
8. History of heparin induced thrombocytopenia (HIT)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sponsor Role
collaborator
Pfizer
INDUSTRY
Sponsor Role
collaborator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Sponsor Role
lead
Responsible Party
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Michael Kovacs
M.D.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Michael J Kovacs, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Western Ontario, Canada
Locations
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QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Site Status
Hamilton Health Sciences Corporation-General Hospital
Hamilton, Ontario, Canada
Site Status
Hamilton Health Sciences Corporation-McMaster Site
Hamilton, Ontario, Canada
Site Status
Hamilton Health Sciences Corporation-Henderson Site
Hamilton, Ontario, Canada
Site Status
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
Site Status
SMBD Jewish General Hospital
Montreal, Quebec, Canada
Site Status
Care Hospital
Hyderabad, Nampally, India
Site Status
Sir Ganga Ram Hospital
New Delhi, , India
Site Status
Countries
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Canada
India
References
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Kearon C, Ginsberg JS, Kovacs MJ, Anderson DR, Wells P, Julian JA, MacKinnon B, Weitz JI, Crowther MA, Dolan S, Turpie AG, Geerts W, Solymoss S, van Nguyen P, Demers C, Kahn SR, Kassis J, Rodger M, Hambleton J, Gent M; Extended Low-Intensity Anticoagulation for Thrombo-Embolism Investigators. Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med. 2003 Aug 14;349(7):631-9. doi: 10.1056/NEJMoa035422.
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Kovacs MJ, Wells PS, Anderson DR, Lazo-Langner A, Kearon C, Bates SM, Blostein M, Kahn SR, Schulman S, Sabri E, Solymoss S, Ramsay T, Yeo E, Rodger MA; PERIOP2 Investigators. Postoperative low molecular weight heparin bridging treatment for patients at high risk of arterial thromboembolism (PERIOP2): double blind randomised controlled trial. BMJ. 2021 Jun 9;373:n1205. doi: 10.1136/bmj.n1205.
Reference Type
DERIVED
Other Identifiers
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NRA6300019
Identifier Type: -
Identifier Source: secondary_id
R-06-267
Identifier Type: -
Identifier Source: org_study_id
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Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
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UNKNOWN
PHASE4
Anticoagulation Length in Cancer Associated Thrombosis
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TERMINATED
PHASE2
Early Versus Late Resumption of Anticoagulation in Patients With Both High Thrombosis Risk and Major HEmoRrhage
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TERMINATED
PHASE3
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation
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COMPLETED
PHASE4
STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism
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UNKNOWN
PHASE3
Delivery and Implementation of a Randomised Crossover Trial on Thrombosis
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NOT_YET_RECRUITING
NA
The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis
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COMPLETED
PHASE2
DOAC - Dosing Options in AntiCoagulation Prophylaxis
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RECRUITING
PHASE3