RivaroxabanPhase 3NCT04309240
Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports
A Phase 3 study testing Rivaroxaban in people with Rivaroxaban and Thromboprophylaxis, run by LiuZhou People's Hospital.
Trial summary
Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rivaroxaban, Thromboprophylaxis, Cancer
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2020to 8 Mar 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with a history of allergies to rivaroxaban;
- History of recent major or clinically relevant bleeding within the previous 4 weeks.
- Patients with bleeding risks: thrombocytopenia (platelet count < 50*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke; Inadequate renal function; creatinine clearance < 30 ml/min；
- Inadequate hepatic function: aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN
- Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments.
- Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk.
- Patients who have had anticoagulant drugs for any other reason.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial
Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.
- Conditions
- Rivaroxaban, Thromboprophylaxis, Cancer
- Being tested
- Rivaroxaban
- Keywords
- Prophylactic Anticoagulation, rivaroxaban, venous thrombosis, Totally Implantable Access Ports, cancer
- Medical subject headings
- Neoplasms, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban 10mg orally per day for 90days
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban | Experimental | oral Rivaroxaban 10mg per day for 90days Receives: Drug: Rivaroxaban |
| blank control | No intervention | mechanical prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of venous thrombosis
detect the occurrence of venous thrombosis with ultrasound, venography if necessary.
Measured: From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months
occurrence of a major bleeding event.
define occurrence of major-bleeding event with ISTH standard
Measured: From date of randomization until the date of occurrence of a major bleeding event or date of death from any cause, whichever came first, assessed up to 6 months
occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event
define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0
Measured: From date of randomization until the date of occurrence of events or date of death from any cause, whichever came first, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start8 Mar 2020 (estimated)
- Primary completion8 Mar 2022 (estimated)
- Study completion8 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RivaroxabanStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiuZhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tingliu, LiuZhou People's Hospital
- Investigators
- yu bin, PHD, Study chair, LiuZhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309240
- Sponsor's protocol ID
- KY-1-2020-07-01
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.
PubMed 30786186Wang TF, Zwicker JI, Ay C, Pabinger I, Falanga A, Antic D, Noble S, Khorana AA, Carrier M, Meyer G. The use of direct oral anticoagulants for primary thromboprophylaxis in ambulatory cancer patients: Guidance from the SSC of the ISTH. J Thromb Haemost. 2019 Oct;17(10):1772-1778. doi: 10.1111/jth.14564. Epub 2019 Jul 28. No abstract available.
PubMed 31353841
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04309240
- Acronym / sponsor ID
- KY-1-2020-07-01
- Conditions
- Rivaroxaban, Thromboprophylaxis, Cancer
- Keywords
- Prophylactic Anticoagulation, rivaroxaban, venous thrombosis, Totally Implantable Access Ports, cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- LiuZhou People's HospitalUniversity, hospital or other
- Study start
- 8 Mar 2020 (estimated)
- Primary completion
- 8 Mar 2022 (estimated)
- Study completion
- 8 Mar 2022 (estimated)
- First posted
- 16 Mar 2020 (actual)
- 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.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban | Experimental | Drug: Rivaroxabanoral Rivaroxaban 10mg per day for 90days |
| blank control | No intervention | –mechanical prophylaxis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Patients with a history of allergies to rivaroxaban;
- History of recent major or clinically relevant bleeding within the previous 4 weeks.
- Patients with bleeding risks: thrombocytopenia (platelet count < 50*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke; Inadequate renal function; creatinine clearance < 30 ml/min；
- Inadequate hepatic function: aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN
- Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments.
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 |
|---|---|---|
| RivaroxabanRivaroxaban 10mg orally per day for 90days | Drug | rivaroxaban |
Primary outcome
occurrence of venous thrombosis
Time frame: From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months
detect the occurrence of venous thrombosis with ultrasound, venography if necessary.
occurrence of a major bleeding event.
Time frame: From date of randomization until the date of occurrence of a major bleeding event or date of death from any cause, whichever came first, assessed up to 6 months
define occurrence of major-bleeding event with ISTH standard
occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event
Time frame: From date of randomization until the date of occurrence of events or date of death from any cause, whichever came first, assessed up to 6 months
define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 30786186Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.
- Background: PubMed 31353841Wang TF, Zwicker JI, Ay C, Pabinger I, Falanga A, Antic D, Noble S, Khorana AA, Carrier M, Meyer G. The use of direct oral anticoagulants for primary thromboprophylaxis in ambulatory cancer patients: Guidance from the SSC of the ISTH. J Thromb Haemost. 2019 Oct;17(10):1772-1778. doi: 10.1111/jth.14564. Epub 2019 Jul 28. No abstract available.
- 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.
yu bin, PHD study chair
LiuZhou People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban in people with Rivaroxaban and Thromboprophylaxis, run by LiuZhou People's Hospital.
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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liu ting, master (13978872445, liuting201070176@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of venous thrombosis (time frame: From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months). The study lists 3 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 NCT04309240, which also lists 2 linked publications.
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 16 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.