PERIOP 2 - A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin.

NCT00432796 | Unknown Phase 3 DMC

• 2 other identifiers: R-06-267NRA6300019
• Study Type: interventional
• Target: 1,473
• Locations: 2 countries
• Sites: 8

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 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.

Conditions

Stroke

Keywords

Anticoagulation; Prosthetic heart valves; Atrial fibrillation; Bridging Therapy; Thromboembolism; Warfarin; Low Molecular Weight Heparin

Outcome Measures

Primary Outcomes (1)

• major thromboembolism

  90 days from randomization

Secondary Outcomes (5)

• major bleeding

  90 days from randomization

• minor bleeding

  90 days from randomization

• a composite of major bleeding and major thromboembolic events

  90 days from randomization

• minor thromboembolic events

  90 days from randomization

• overall survival.

  90 days from randomization

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Drug: Dalteparin

2

EXPERIMENTAL

patients will be randomized post-operative to receive either active treatment or placebo

Other: Placebo

Interventions

Dalteparin 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

Also known as: Fragmin

1

Placebo 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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Pfizer: collaborator

Study Sites (8)

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Hamilton Health Sciences Corporation-General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Hamilton Health Sciences Corporation-McMaster Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hamilton Health Sciences Corporation-Henderson Site

Hamilton, Ontario, L8V 1C3, Canada

Location

Ottawa Hospital-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

SMBD Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Care Hospital

Hyderabad, Nampally, 500001, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

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MeSH Terms

Conditions

Stroke; Atrial Fibrillation; Thromboembolism

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Michael J Kovacs, MD, FRCPC

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 8, 2007
• Study Start: December 1, 2006
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6); IN (2)