Condition category
Circulatory System
Date applied
27/09/2007
Date assigned
27/09/2007
Last edited
05/08/2013
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 David Robert Anderson

ORCID ID

Contact details

Queen Elizabeth II (QEII) Health Sciences Centre and Dalhousie University
Room 430 Bethune Building
4th floor
1278 Tower Road
Halifax
Nova Scotia
B3H 2Y9
Canada
+1 902 473 8562
David.Anderson@cdha.nshealth.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-82948

Study information

Scientific title

Acronym

EPCAT

Study hypothesis

Current hypothesis as of 05/12/2007:
Extending the duration of anti-thrombotic prophylaxis with aspirin by 28 days following a ten day course of Low Molecular Weight Heparin (LMWH) will be as effective at reducing the rate of symptomatic venous thromboembolic complications and will be safe and more cost-effective than extending prophylaxis by 28 days with LMWH in a group of patients undergoing total hip arthroplasty.

Previous hypothesis:
Extending the duration of anti-thrombotic prophylaxis with aspirin by 28 days following a minimum seven day course of Low Molecular Weight Heparin (LMWH) will be as effective at reducing the rate of symptomatic venous thromboembolic complications and will be safe and more cost-effective than extending prophylaxis by 28 days with LMWH in a group of patients undergoing total hip arthroplasty.

Please note that this record has been updated on the 5th December 2007 due to changes made to this protocol by the suggestion of the Research Ethics Board (REB). All changes were made prior to the recruitment of the first study participant and will be entered in this record under the date 05/12/2007.

Ethics approval

Research Ethics Board of Capital District Health Authority, Halifax, Nova Scotia, Canada approved on the 17th September 2007 (ref: CDHA-RS/2007-179)

Study design

Multicentre, two arm, randomised parallel trial, using placebo, with study participant, research coordinator, study investigator, caregiver, outcome assessor, and data analyst blinded

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Venous thromboembolism following total hip arthoplasty

Intervention

Current interventions as of 05/12/2007:
1. Aspirin: 81 mg once a day for 28 days
2. Dalteparin: 5000 i.u. subcutaneously once a day
3. Matching placebo (aspirin): one pill once a day for 28 days
4. Matching placebo (dalteparin-normal saline): injection subcutaneously once a day for 28 days

Previous interventions:
1. Aspirin: 81 mg once a day for 28 days
2. Enoxaparin: 40 mg subcutaneously once a day for 28 days
3. Matching placebo (aspirin): one pill once a day for 28 days
4. Matching placebo (enoxaparin): injection subcutaneously once a day for 28 days

Contact for public queries:
Susan Pleasance, Associate Director
Haematology Research
Centre for Clinical Research
5790 University Avenue, Room 132
Halifax, Nova Scotia
B3H 1V7
Canada
Tel: +1 902 473 7585
Fax: +1 902 473 4667
Email: Susan.Pleasance@cdha.nshealth.ca

Intervention type

Drug

Phase

Not Applicable

Drug names

Aspirin, dalteparin

Primary outcome measures

Current primary outcome measures as of 15/01/2008:
Venous thromboembolism (pulmonary embolism of deep vein thrombosis), assessed at 90 days.

Previous primary outcome measures:
1. Symptomatic venous thromboembolic complications, assessed at 90 days
2. Venous thromboembolism (pulmonary embolism of deep vein thrombosis), assessed at 90 days

Secondary outcome measures

Current secondary outcome measures as of 15/01/2008:
1. Survival, assessed at 90 days
2. Major bleeding, assessed at 90 days
3. Wound infection, assessed at 90 days
4. Stroke, assessed at 90 days
5. Thrombocytopenia, assessed at 90 days
6. Cost effectiveness, assessed at 90 days

Previous secondary outcome measures:
1. Survival, assessed at 90 days
2. Major bleeding, assessed at 90 days
3. Myocardial infarction, assessed at 90 days
4. Stroke, assessed at 90 days
5. Cost effectiveness, assessed at 90 days

Overall trial start date

01/09/2007

Overall trial end date

30/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing elective total hip arthroplasty at the participating institutions
2. Age 18 years and older, either sex. However, please note that if a patient under 18 years presents to the clinic (although this is unlikely), they will be included.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2200 (2222 as of 05/12/2007)

Participant exclusion criteria

Added as of 25/02/2009:
15. Investigator decision
16. Bilateral total hip arthroplasty (THA) or simultaneous hip and knee surgery
17. Unable to give consent
18. Geographical inaccessibility
19. Requirement for major surgery within 28 day study-drug period

Amended as of 05/12/2007:
1. Hip fracture in the previous three months
2. Metastatic cancer
3. Life expectancy less than 6 months
4. History of major bleeding that, in the judgement of the investigator, precludes use of anticoagulant prophylaxis
5. History of aspirin allergy, active peptic ulcer disease or gastritis that, in the judgment of the investigator, precludes use of aspirin
6. History of heparin induced thrombocytopenia or heparin allergy
7. Creatine clearance less than 30 ml per minute
8. Platelet count less than 100 x 10^9/L
9. Need for long-term anticoagulation due to pre-existing co-morbid conditions or due to the development of venous thromboembolism following surgery but prior to randomisation
10. Need for aspirin over the course of the study due to pre-existing co-morbid condition
11. Previous participation in this study
12. Refusal to give informed consent
13. Did not, or will not, receive dalteparin post-operatively for Venous Thromboembolism (VTE) prophylaxis
14. Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period

Initial information at time of registration:
1. Hip fracture in the previous three months
2. Metastatic cancer
3. Life expectancy less than 6 months
4. History of major bleeding that, in the judgement of the investigator, precludes use of anticoagulant prophylaxis
5. History of aspirin allergy, active peptic ulcer disease or gastritis that, in the judgment of the investigator, precludes use of aspirin
6. History of heparin induced thrombocytopenia or heparin allergy
7. Chonic renal failure (creatine clearance less than 30 ml per minute)
8. Platelet count less than 100 x 10^9/L
9. Need for long-term anticoagulation due to pre-existing co-morbid conditions or due to the development of venous thromboembolism following surgery but prior to randomisation
10. Need for aspirin over the course of the study due to pre-existing co-morbid condition
11. Previous participation in this study
12. Geographic inaccessibility for follow-up
13. Refusal to give informed consent

Recruitment start date

01/09/2007

Recruitment end date

30/03/2011

Locations

Countries of recruitment

Canada

Trial participating centre

Queen Elizabeth II (QEII) Health Sciences Centre and Dalhousie University
Halifax, Nova Scotia
B3H 2Y9
Canada

Sponsor information

Organisation

Dalhousie University (Canada) - Research Services

Sponsor details

Room 321
Henry Hicks Academic Administration Building
6299 South Street
Halifax
Nova Scotia
B3H 4H6
Canada
+1 902 494 6513
researchservices@dal.ca

Sponsor type

University/education

Website

http://www.dal.ca/research/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-82948)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bayer Healthcare (Canada)

Alternative name(s)

BHC

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

Funder name

Pfizer (Canada) - added 05/12/2007

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23732713

Publication citations

  1. Results

    Anderson DR, Dunbar MJ, Bohm ER, Belzile E, Kahn SR, Zukor D, Fisher W, Gofton W, Gross P, Pelet S, Crowther M, MacDonald S, Kim P, Pleasance S, Davis N, Andreou P, Wells P, Kovacs M, Rodger MA, Ramsay T, Carrier M, Vendittoli PA, Aspirin versus low-molecular-weight heparin for extended venous thromboembolism prophylaxis after total hip arthroplasty: a randomized trial., Ann. Intern. Med., 2013, 158, 11, 800-806, doi: 10.7326/0003-4819-158-11-201306040-00004.

Additional files

Editorial Notes