Condition category
Circulatory System
Date applied
04/06/2008
Date assigned
04/06/2008
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Joseph Kovacs

ORCID ID

Contact details

Victoria Hospital
800 Commissioners Road East
Room A2-401
London
Ontario
N6A 4G5
Canada
+1 519 685 8475
michael.kovacs@lhsc.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00432796

Protocol/serial number

MCT-79607

Study information

Scientific title

A double blind randomised controlled trial of post-operative low molecular weight heparin bridging therapy versus placebo bridging therapy for patients who are at high risk for arterial thromboembolism

Acronym

PERIOP2

Study hypothesis

Efficacy:
Omitting post-operative bridging therapy with low molecular weight heparin (LMWH) will reduce the risk of thromboembolic complications in patients with prosthetic heart valves or atrial fibrillation who are at high risk for arterial embolism when warfarin is temporarily interrupted.

Safety:
Omitting post-operative bridging therapy with LMWH will reduce the risk of bleeding complications in patients with prosthetic heart valves or atrial fibrillation who are at high risk for arterial embolism when warfarin is temporarily interrupted.

Ethics approval

1. Research Ethics Board of the University of Western Ontario approved on the 12th September 2006 (ref: 12559)
2. Research Ethics Board of Ottawa Hospital, General Campus approved on the 20th October 2008 (ref: 2006513-01H)
3. Capital Health Research Ethics Board approved on the 27th September 2006 (ref: CDHA-RS/2006-247)
4. Hamilton Health Sciences Research Ethics Board approved on the 17th November 2006 (ref: 06-363)
5. McGill University Health Centre Research Ethics Board approved on the 2nd March 2007 (ref: 06-038)
6. SMBD-Jewish General Hospital Research Ethics Committee approved on the 4th October 2006 (ref: 06-078)
7. St. Paul's Hospital - Providence Health Care Research Institute approved on the 6th June 2007 (ref: H07-01391)
8. Toronto General Hospital - University Health Network Research Ethics Board approved on the 24th April 2008 (ref: 07-0788-A)

Study design

Multicentre, two arm, randomised parallel trial with study participant, study investigator, caregiver, and outcome assessor blinded

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Arterial thromboembolism

Intervention

Experimental:
1. Placebo 5,000 units subcutaneously once a day for four days post-operatively or until the International Normalised Ratio (INR) is greater than 2.0, or
2. Placebo 200 units subcutaneously once a day for four days post-operatively or until the INR is greater than 2.0

Control:
1. Dalteparin 5,000 units subcutaneously once a day for four days post-operatively or until the INR is greater than 2.0, or
2. Dalteparin 200 units subcutaneously once a day for four days post-operatively or until the INR is greater than 2.0

Intervention type

Drug

Phase

Not Applicable

Drug names

Dalteparin

Primary outcome measures

Major thromboembolism including:
1. Ischaemic stroke
2. Symptomatic myocardial infarction
3. Peripheral embolism
4. Valve thrombosis
5. Venous thromboembolism
6. Vascular death

Outcomes will be measured at three months.

Secondary outcome measures

1. Minor thromboembolism
2. Major bleeding
3. Minor bleeding
4. Overall survival

Outcomes will be measured at three months.

Overall trial start date

01/05/2006

Overall trial end date

01/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent
2. Patients of either sex, 18 years and older, with prosthetic heart valves receiving long-term oral anticoagulation with warfarin, or
3. Patients with atrial fibrillation and a major risk factor (previous transient ischaemic attack (TIA) or stroke, high blood pressure, diabetes, 75 years and older, moderate/severe left ventricle dysfunction), who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1773

Participant exclusion criteria

1. Evidence of active bleeding prior to stopping warfarin
2. Platelet count less than 100 x 10^9/L
3. Spinal or neurosurgery
4. Life expectancy less than three months
5. Serum creatinine greater than 150 umol/L
6. Patients requiring cardiac surgery
7. Multiple prosthetic valves or Starr-Edwards valves or prosthetic valves with a history of stroke or TIA

Recruitment start date

01/05/2006

Recruitment end date

01/05/2011

Locations

Countries of recruitment

Canada

Trial participating centre

Victoria Hospital
London, Ontario
N6A 4G5
Canada

Sponsor information

Organisation

London Health Sciences Centre (Canada)

Sponsor details

370 South Street
Nurses Residence
Room C210
London
Ontario
N6A 4G5
Canada
+1 519 685 8500 ext. 75727
don.atkinson@lhsc.on.ca

Sponsor type

Research organisation

Website

http://www.lhsc.on.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79607)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Canada Inc. (Canada) - medication only

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes