Symptomatic Superficial Vein ThrombosisPhase 3RASETNCT02123524
Rivaroxaban Anticoagulation for Superficial Vein Thrombosis
A Phase 3 study testing Rivaroxaban in people with Symptomatic Superficial Vein Thrombosis, run by McMaster University at 11 sites in Canada.
Trial summary
This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg Superficial Vein Thrombosis (> or = 5cm) that otherwise would not initially be treated with anticoagulant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Superficial Vein Thrombosis
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 11 sitesCanada
- Study dates
- 11 Nov 2014to 3 Dec 2018
- 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
- Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound)
Who cannot join
- Age <18 years
- Symptoms >42 days
- Receiving an anticoagulant for another indication (example: atrial fibrillation) when Superficial Vein Thrombosis started.
- Superficial Vein Thrombosis already treated with more than 3 days of anticoagulation (example. fondaparinux or Low Molecular Weight Heparin).
- Planned treatment of Superficial Vein Thrombosis with a course of anticoagulant therapy.
- Another indication for anticoagulant therapy (example. Deep Vein Thrombosis, Pulmonary Embolism, atrial fibrillation).
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- Judged to require immediate ligation of the saphenofemoral junction or stripping of thrombosed varicose veins.
- proximal Deep Vein Thrombosis or Pulmonary Embolism within the past 12 months.
- Superficial Vein Thrombosis associated with sclerotherapy or an intravenous canula.
- A high risk of bleeding as evidenced by any of the following:
- Active bleeding
- Bleeding within the past 30 days due to a cause that has not fully resolved.
- Known or expected thrombocytopenia with a platelet count of less than 80,000 x 10 9/L.
- History of ever having had spontaneous intracranial bleeding, or any intracranial bleeding within the past 3 months.
- Receiving dual antiplatelet therapy (example. aspirin and clopidogrel).
- Elevated creatinine level is suspected and creatinine clearance has not been estimated, OR creatinine clearance (Cockcroft-Gault equation) of less than 30 ml/min.
- Clinically relevant hepatic disease (including Child-Pugh B and C) is known or suspected (example., associated with: International Normalized Ratio >1.7; total bilirubin >2 upper limit of normal; or Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >3 times upper limit of normal).
- Ongoing requirement for systemic treatment with azole-antimycotics (except fluconazole), Human Immunodeficiency Virus (HIV) -protease inhibitors, or strong Cytochrome P450 3A4 (CYP3A4) inducers due to the potential interaction with rivaroxaban.
- Pregnant or lactating women, or at risk of becoming pregnant.
- Life expectancy less than 90 days
- Patient is unwilling or unable to comply with the protocol (example. unable to attend follow-up visits because of geographic inaccessibility).
- Participating in a competing clinical investigation and receiving any other investigational agent(s).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton General Hospital
Hamilton, Ontario, L8L2X2
St Josephs Healthcare
Hamilton, Ontario, L8N4A6
Juravinski Hospital
Hamilton, Ontario, L8V1C3
McMaster Hospital
Hamilton, Ontario
Hopital Maisonneuve - Rosemount
Montreal, Quebec, H1T 2M4
Jewish General Hospital
Montreal, Quebec, H3T1E2
Hopital Sacre Coeur
Montreal, Quebec, H4J1C5
Montreal General Hospital
Montreal, Quebec
St Mary's Hospital
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
About this study
Official title: A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis
This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg Superficial Vein Thrombosis (> or = 5cm) that otherwise would not initially be treated with anticoagulant therapy.
Read the detailed description
Patients with symptomatic superficial leg thrombosis will be randomized into two arms, a) rivaroxaban 10mg 1 tablet daily for 45 days or b) placebo to determine if rivaroxaban (10 mg once daily) is an effective and safe treatment for superficial vein thrombosis.
- Conditions
- Symptomatic Superficial Vein Thrombosis
- Being tested
- Rivaroxaban, Placebo
- Keywords
- Superficial Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Rivaroxaban 10mg tablet daily for 45 days Receives: Drug: Rivaroxaban |
| Control | Placebo comparator | Placebo tablet daily for 45 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
"Treatment failure" at 90 days (composite of: treated with non-study anticoagulant therapy; proximal Deep Vein Thrombosis or Pulmonary Embolism; surgery for Superficial Vein Thrombosis).
Measured: 90 days
Safety
Major bleeding within 90 days.
Measured: 90 Days
Secondary outcomes (5)
Efficacy
The patient will self assess any change in leg pain using a Likert Scale.
Measured: Baseline,Day 7, Day 45 and Day 90
Efficacy
Patients will rate any change in venous disease-specific quality of life (QOL) (VEINES-QOL and VEINES-Symptoms) and general health-related QOL (SF-36v2) at 45 days
Measured: Baseline and day 45
Efficacy
Any use of oral analgesics and oral/topical anti-inflammatory agents.
Measured: Baseline, day 7, day 45 and day 90
Safety
Death
Measured: 90 days
Safety
major and minor bleeding
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study start11 Nov 2014
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Superficial Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Clive Kearon, MD, Principal investigator, McMaster University/ Hamilton Health Sciences, Juravinski Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123524
- Sponsor's protocol ID
- OCOG-2013-RASET
- Acronym
- RASET
- Status last verified
- Dec 2018
- First submitted
- 23 Apr 2014
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis
- ClinicalTrials.gov ID
- NCT02123524
- Acronym / sponsor ID
- RASET / OCOG-2013-RASET
- Conditions
- Symptomatic Superficial Vein Thrombosis
- Keywords
- Superficial Vein Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 25 Apr 2014 (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.
This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg Superficial Vein Thrombosis (> or = 5cm) that otherwise would not initially be treated with anticoagulant therapy.
Detailed description
Patients with symptomatic superficial leg thrombosis will be randomized into two arms, a) rivaroxaban 10mg 1 tablet daily for 45 days or b) placebo to determine if rivaroxaban (10 mg once daily) is an effective and safe treatment for superficial vein thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanRivaroxaban 10mg tablet daily for 45 days |
| Control | Placebo comparator | Drug: PlaceboPlacebo tablet daily for 45 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound)
Key exclusion criteria (22 listed)
- Age <18 years
- Symptoms >42 days
- Receiving an anticoagulant for another indication (example: atrial fibrillation) when Superficial Vein Thrombosis started.
- Superficial Vein Thrombosis already treated with more than 3 days of anticoagulation (example. fondaparinux or Low Molecular Weight Heparin).
- Planned treatment of Superficial Vein Thrombosis with a course of anticoagulant therapy.
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 | Drug | Rivaroxaban |
| Placebo | Drug | Control |
Primary outcome
Efficacy
Time frame: 90 days
"Treatment failure" at 90 days (composite of: treated with non-study anticoagulant therapy; proximal Deep Vein Thrombosis or Pulmonary Embolism; surgery for Superficial Vein Thrombosis).
Safety
Time frame: 90 Days
Major bleeding within 90 days.
5 secondary outcomes
Efficacy
Time frame: Baseline,Day 7, Day 45 and Day 90
Efficacy
Time frame: Baseline and day 45
Efficacy
Time frame: Baseline, day 7, day 45 and day 90
Safety
Time frame: 90 days
Safety
Time frame: 45 days
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 4 Dec 2018.
- Related InfoLink provided by the sponsor.
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.
Clive Kearon, MD principal investigator
McMaster University/ Hamilton Health Sciences, Juravinski Hospital
11 sites 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 in people with Symptomatic Superficial Vein Thrombosis, run by McMaster University at 11 sites 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 22 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. 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?
Efficacy (time frame: 90 days). 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?
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 4 Dec 2018.