RivaroxabanPhase 4NCT01989845
Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer
A Phase 4 study testing Rivaroxaban in people with Rivaroxaban and Cancer-associated Thrombosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Rivaroxaban has been developed in the various clinical settings, prevention of venous thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial fibrillation, and in the treatment of acute coronary syndromes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rivaroxaban, Cancer-associated Thrombosis, Recurrence
- What is being tested?
- Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 20 years old and active cancer and newly-diagnosed, symptomatic or incidental proximal lower extremity DVT, PE or both
- will have a life expectancy > 3 months
- will be treated with anticoagulation therapy for at least 3 months.
Who cannot join
- (1) Isolated asymptomatic distal DVT
- (2) Intra-abdominal venous thrombosis or vascular access-induced thrombosis
- (3) Hemodynamically unstable PE, indicating systolic blood pressure <90 mmHg
- (4)Eastern Cooperative Oncology Group (ECOG) performance status score of 3 or 4
- (5) History of total gastrectomy
- (6) Overt brain metastasis. Patients who have controlled brain metastasis without need of glucocorticoid are eligible
Show all 16Show fewer
- (7) History of recent major or clinically relevant bleeding within the previous 4 weeks
- (8) Conditions associated with a high risk of serious bleeding (active peptic ulcer or recent neurosurgery)
- (9) Other serious illness or medical conditions (illnesses requiring chronic anticoagulation therapy, unstable cardiac disease despite treatment, myocardial infarction within 3 months prior to study entry, significant neurologic or psychiatric diseases including dementia or seizure, active uncontrolled infection, other serious medical conditions)
- (10)Inadequate renal function; creatinine clearance < 30 ml/min
- (11) Inadequate hepatic function: alanine aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN or total bilirubin >2 times the ULN (if liver metastasis, total bilirubin >3 times the ULN)
- (12) Baseline platelet count < 75,000 per cubic millimeter or Hb < 8g/dL
- (13) Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk
- (14) Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period, who are using a prohibited contraceptive method, or who are pregnant or breastfeeding
- (15) Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments
- (16) Patients with inferior vena cava filter placement or underwent catheter-directed thrombolysis or stent placement for the treatment of index VTE
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 463-707
About this study
Official title: Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism in Korean Patients With Cancers
Rivaroxaban has been developed in the various clinical settings, prevention of venous thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial fibrillation, and in the treatment of acute coronary syndromes. And, in the EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs, rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT. However, there has been limited experience of rivaroxaban with secondary VTE prophylaxis in cancer patients. Although cancer-associated DVT or PE was included in previously mentioned EINSTEIN programs, only approximately 5% of the total populations were cancer patients in these studies. Thus, investigators could not automatically translate the results of these studies into the real practice management of cancer-associated VTE patients. Moreover, until now, new oral anticoagulants, including dabigatran and rivaroxaban, have been compared to long-term warfarin therapy, which were well-known inferior agent, but not low molecular weight heparin. In this sense, investigators feel that new oral anticoagulants, particularly rivaroxaban, should be re-investigated in this highly specific patients group. Therefore, investigators are planning to conduct a prospective study evaluating the efficacy and safety of rivaroxaban in Korean patients with cancer-associated VTE.
- Conditions
- Rivaroxaban, Cancer-associated Thrombosis, Recurrence, Bleeding
- Being tested
- Rivaroxaban
- Medical subject headings
- Recurrence, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
Rivaroxaban 15mg twice daily for the first 3 weeks, followed by 20mg once daily during 6 months
| Study group | Role | What they receive |
|---|---|---|
| oral rivaroxaban in cancer-associated VTE | Experimental | Not described Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent symptomatic deep venous thrombosis, pulmonary embolism or both
Recurrent DVT will be defined if a new onset non-compressibility of a previously compressible venous segment on ultrasonography is identified or if there is a new constant intraluminal filling defect on venography. Unequivocal extension of the thrombus will be needed to diagnose the recurrence on the same extremity of the first event unless new concomitant PE or DVT in other extremities is confirmed.
Recurrent PE will be diagnosed by high probability on ventilation/perfusion lung scan, or by the presence of non-enhancing filling defects in the pulmonary vasculature on pulmonary CT angiogram.
Measured: within the six months after the diagnosis of index VTE
Secondary outcomes (3)
incidentally detected VTE
Incidentally detected recurrent thrombosis will be defined as objectively-proven thrombosis during the study period by imaging studies that are performed for reasons other than suspected VTE.
Measured: within six months after the diagnosis of VTE
Major or clinically relevant non-major bleedings
Major bleeding will be defined if it is associated with death, occurs at critical sites (intracranial, intraspinal, intraocular, retroperitoneal, or pericardial area), and results in a need for a transfusion of at least 2 units of packed red cells, or lead to a drop in hemoglobin of more than 2 g/dL.
Clinically relevant non-major bleeding will be defined as relevant bleeding that did not meet the criteria for major bleeding but is associated with medical intervention, unscheduled visit, interruption or discontinuation of a study drug, or discomfort or impairment of activities of daily life
Measured: within six months after the diagnosis of VTE
recurrent VTE according to the risk of clinical prediction rule
Risk of recurrent VTE can be differentiated by risk prediction rule, named Ottawa score. Ottawa score is composed of gender, primary tumor site, stage, and prior VTE and ranged between -3 and 3 score points. Patients with a score <1 will be considered as having low risk for recurrence and patients with a score >1 considered as having high risk for recurrence.
Measured: within six months after the diagnosis of VTE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RivaroxabanStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society of Hematology Thrombosis Working Party
- Responsible party
- Principal investigator, Soo-Mee Bang, Seoul National University Hospital
- Investigators
- Soo-Mee Bang, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989845
- Sponsor's protocol ID
- KVTE13-01
- Status last verified
- Jan 2017
- First submitted
- 5 Nov 2013
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism in Korean Patients With Cancers
- ClinicalTrials.gov ID
- NCT01989845
- Acronym / sponsor ID
- KVTE13-01
- Conditions
- Rivaroxaban, Cancer-associated Thrombosis, Recurrence, Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Society of Hematology Thrombosis Working Party
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Nov 2013 (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.
Rivaroxaban has been developed in the various clinical settings, prevention of venous thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial fibrillation, and in the treatment of acute coronary syndromes. And, in the EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs, rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT. However, there has been limited experience of rivaroxaban with secondary VTE prophylaxis in cancer patients. Although cancer-associated DVT or PE was included in previously mentioned EINSTEIN programs, only approximately 5% of the total populations were cancer patients in these studies. Thus, investigators could not automatically translate the results of these studies into the real practice management of cancer-associated VTE patients. Moreover, until now, new oral anticoagulants, including dabigatran and rivaroxaban, have been compared to long-term warfarin therapy, which were well-known inferior agent, but not low molecular weight heparin. In this sense, investigators feel that new oral anticoagulants, particularly rivaroxaban, should be re-investigated in this highly specific patients group. Therefore, investigators are planning to conduct a prospective study evaluating the efficacy and safety of rivaroxaban in Korean patients with cancer-associated VTE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral rivaroxaban in cancer-associated VTE | Experimental | Drug: Rivaroxaban |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 20 years old and active cancer and newly-diagnosed, symptomatic or incidental proximal lower extremity DVT, PE or both
- will have a life expectancy > 3 months
- will be treated with anticoagulation therapy for at least 3 months.
Key exclusion criteria (16 listed)
- (1) Isolated asymptomatic distal DVT
- (2) Intra-abdominal venous thrombosis or vascular access-induced thrombosis
- (3) Hemodynamically unstable PE, indicating systolic blood pressure <90 mmHg
- (4)Eastern Cooperative Oncology Group (ECOG) performance status score of 3 or 4
- (5) History of total gastrectomy
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 |
|---|---|---|
| RivaroxabanAlso: XareltoRivaroxaban 15mg twice daily for the first 3 weeks, followed by 20mg once daily during 6 months | Drug | oral rivaroxaban in cancer-associated VTE |
Primary outcome
recurrent symptomatic deep venous thrombosis, pulmonary embolism or both
Time frame: within the six months after the diagnosis of index VTE
Recurrent DVT will be defined if a new onset non-compressibility of a previously compressible venous segment on ultrasonography is identified or if there is a new constant intraluminal filling defect on venography. Unequivocal extension of the thrombus will be needed to diagnose the recurrence on the same extremity of the first event unless new concomitant PE or DVT in other extremities is confirmed. Recurrent PE will be diagnosed by high probability on ventilation/perfusion lung scan, or by the presence of non-enhancing filling defects in the pulmonary vasculature on pulmonary CT angiogram.
3 secondary outcomes
incidentally detected VTE
Time frame: within six months after the diagnosis of VTE
Major or clinically relevant non-major bleedings
Time frame: within six months after the diagnosis of VTE
recurrent VTE according to the risk of clinical prediction rule
Time frame: within six months after the diagnosis of VTE
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 9 Jan 2017.
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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.
Soo-Mee Bang, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban in people with Rivaroxaban and Cancer-associated Thrombosis, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 16 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 9 Jan 2017. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
recurrent symptomatic deep venous thrombosis, pulmonary embolism or both (time frame: within the six months after the diagnosis of index VTE). 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 9 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.