Venous ThromboembolismPhase 3EPCAT IINCT01720108
Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty
A Phase 3 study testing rivaroxaban and ASA in people with Venous Thromboembolism, run by David Anderson at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- rivaroxaban and ASA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,426 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2013to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. All patients undergoing elective total hip or knee arthroplasty at the participating institutions will be potentially eligible for this study
Who cannot join
- 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
Show all 19Show fewer
- 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
- Concomitant use with drugs that are strong inhibitors or inducers of both P-gp and CYP3A4
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Venous Thromboembolism
- Being tested
- rivaroxaban and ASA
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxaban and ASADrug
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban | Active comparator | rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients Receives: Drug: rivaroxaban and ASA |
| ASA | Experimental | ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients Receives: Drug: rivaroxaban and ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic venous thromboembolism
Measured: up to 4 years
major or clinically relevant non-major bleeding
Measured: up to 4 years
Secondary outcomes (5)
survival
Measured: up to 4 years
myocardial infarction
Measured: up to 4 years
stroke
Measured: up to 4 years
wound infection
Measured: up to 4 years
cost-effectiveness
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study start24 Feb 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,426 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Anderson
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, David Anderson, Nova Scotia Health Authority
- Investigators
- David R Anderson, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720108
- Sponsor's protocol ID
- EPCATII.001
- Acronym
- EPCAT II
- Status last verified
- Jan 2018
- First submitted
- 30 Oct 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Anderson DR, Dunbar M, Murnaghan J, Kahn SR, Gross P, Forsythe M, Pelet S, Fisher W, Belzile E, Dolan S, Crowther M, Bohm E, MacDonald SJ, Gofton W, Kim P, Zukor D, Pleasance S, Andreou P, Doucette S, Theriault C, Abianui A, Carrier M, Kovacs MJ, Rodger MA, Coyle D, Wells PS, Vendittoli PA. Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty. N Engl J Med. 2018 Feb 22;378(8):699-707. doi: 10.1056/NEJMoa1712746.
PubMed 29466159
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01720108
- Acronym / sponsor ID
- EPCAT II / EPCATII.001
- Conditions
- Venous Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,426 participants (actual)
- Lead sponsor
- David AndersonUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 24 Feb 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban | Active comparator | Drug: rivaroxaban and ASArivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients |
| ASA | Experimental | Drug: rivaroxaban and ASAASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All patients undergoing elective total hip or knee arthroplasty at the participating institutions will be potentially eligible for this study
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rivaroxaban and ASA | Drug | ASA, rivaroxaban |
Primary outcome
symptomatic venous thromboembolism
Time frame: up to 4 years
major or clinically relevant non-major bleeding
Time frame: up to 4 years
5 secondary outcomes
survival
Time frame: up to 4 years
myocardial infarction
Time frame: up to 4 years
stroke
Time frame: up to 4 years
wound infection
Time frame: up to 4 years
cost-effectiveness
Time frame: up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Derived from this study: PubMed 29466159Anderson DR, Dunbar M, Murnaghan J, Kahn SR, Gross P, Forsythe M, Pelet S, Fisher W, Belzile E, Dolan S, Crowther M, Bohm E, MacDonald SJ, Gofton W, Kim P, Zukor D, Pleasance S, Andreou P, Doucette S, Theriault C, Abianui A, Carrier M, Kovacs MJ, Rodger MA, Coyle D, Wells PS, Vendittoli PA. Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty. N Engl J Med. 2018 Feb 22;378(8):699-707. doi: 10.1056/NEJMoa1712746.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Anderson, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rivaroxaban and ASA in people with Venous Thromboembolism, run by David Anderson at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic venous thromboembolism (time frame: up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01720108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.