Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty (EPCAT II)
This study is currently recruiting participants.
Verified February 2013 by Capital District Health Authority, Canada
Sponsor:
David Anderson
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Anderson, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01720108
First received: October 30, 2012
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
In this study the investigators want to look at whether using aspirin instead of rivaroxaban (after initial treatment with rivaroxaban) works as well at preventing blood clots while also reducing risk of bleeding and is more cost effective in patients who have either a total hip replacement or total knee replacement.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism Prevention |
Drug: rivaroxaban and ASA |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty |
Resource links provided by NLM:
Further study details as provided by Capital District Health Authority, Canada:
Primary Outcome Measures:
- symptomatic venous thromboembolism [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
- major or clinically relevant non-major bleeding [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- survival [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
- myocardial infarction [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
- stroke [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
- wound infection [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
- cost-effectiveness [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 3426 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: rivaroxaban
rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
|
Drug: rivaroxaban and ASA |
|
Experimental: ASA
ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
|
Drug: rivaroxaban and ASA |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
1. All patients undergoing elective total hip or knee arthroplasty at the participating institutions will be potentially eligible for this study
Exclusion Criteria:
- Hip or lower limb fracture in the previous three months
- Metastatic cancer
- Life expectancy less than 6 months
- History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
- History of aspirin allergy, active peptic ulcer disease or gastritis that in judgment of investigator precludes use of aspirin
- History of significant hepatic disease or any other condition that in the judgement of the investigator precludes the use of rivaroxaban
- Creatinine clearance less than 30 ml per minute
- Platelet count less than 100 x 109 /L
- Need for long-term anticoagulation due to a preexisting co-morbid condition or due to the development of venous thromboembolism following surgery but prior to randomization
- Did not or will not receive rivaroxaban post-operatively for VTE prophylaxis
- Bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty
- Major surgical procedure within the previous three months
- Requirement for major surgery post arthroplasty within 90 day period
- Chronic daily aspirin use with dose greater than 100 mg a day
- Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period
- Geographical inaccessibility for follow-up
- Unwilling or unable to give consent
- Previous participation in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720108
Locations
| Canada, Nova Scotia | |
| Capital Health | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Contact: Allan Hennigar allan.hennigar@cdha.nshealth.ca | |
| Principal Investigator: Michael Dunbar, MD | |
Sponsors and Collaborators
David Anderson
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | David R Anderson, MD | Capital District Health Authority, Canada |
More Information
No publications provided
| Responsible Party: | David Anderson, Head, Department of Medicine, CDHA, Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT01720108 History of Changes |
| Other Study ID Numbers: | EPCATII.001 |
| Study First Received: | October 30, 2012 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on June 17, 2013