Venous ThrombosisPhase 4ONCO PENCT04724460
Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
A Phase 4 study testing Long DOAC and Short DOAC in people with Venous Thrombosis and Neoplasms, run by Takeshi Morimoto at 1 site in Japan.
Trial summary
The primary purpose of this study is to determine the optimal duration of anticoagulation therapy (6 months versus 18 months) with direct oral anticoagulant (DOAC) for cancer-associated low-risk pulmonary embolism patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Venous Thrombosis, Neoplasms, Anticoagulants
- What is being tested?
- Long DOAC and Short DOAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteJapan
- Study dates
- 18 Feb 2021to 31 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active cancer (solid and hematologic malignancies) presenting with objectively newly confirmed pulmonary embolism who are scheduled to be treated by anticoagulation therapy.
- Patients with an simplified Pulmonary Embolism Severity Index (PESI) score of 1 or less
Who cannot join
- Contraindicated patients for rivaroxaban (Clinically significant liver disease, Bacterial endocarditis, Active bleeding, Inadequate contraceptive measures if of childbearing potential, Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers or P-glycoprotein inhibitors or inducers)
- Expected life expectancy <6 months
- Patients who do not provide written informed consent
- Patients who judged to be inappropriate for enrolment by the physician (including patients at a high risk of gastrointestinal or genitourinary bleeding)
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto, Kyoto, 606-8507
About this study
The primary purpose of this study is to determine the optimal duration of anticoagulation therapy (6 months versus 18 months) with direct oral anticoagulant (DOAC) for cancer-associated low-risk pulmonary embolism patients. The major secondary purpose of this study is to investigate whether home treatment of cancer-associated low-risk pulmonary embolism patients with rivaroxaban is feasible, effective, and safe through an observational management study.
Read the detailed description
Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating VTE, although data on low-risk PE, including incidental PE and asymptomatic PE has been quite limited. However, low-risk PE was reported to account for a large proportion of all the diagnoses of PE detected on computed tomography in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines weakly suggest the same approach for low-risk PE patients with cancer as other PE patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that low-risk patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, the investigators randomly assign low-risk PE patients with active cancer to receive either rivaroxaban for 6 months (short DOAC group) or rivaroxaban for 18 months (long DOAC group).
- Conditions
- Venous Thrombosis, Neoplasms, Anticoagulants
- Being tested
- Long DOAC, Short DOAC
- Keywords
- Venous Thrombosis, Neoplasms, Anticoagulants
- Medical subject headings
- Venous Thrombosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long DOACDrug
Administration of Rivaroxaban for 18 months
Short DOACDrug
Administration of Rivaroxaban for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Long DOAC | Active comparator | Administration of Rivaroxaban for 18 months Receives: Drug: Long DOAC |
| Short DOAC | Active comparator | Administration of Rivaroxaban for 6 months Receives: Drug: Short DOAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE recurrence event Venous thromboembolism (VTE) recurrence event
VTE recurrence event is defined as pulmonary embolism (PE) and/or deep vein thrombosis (DVT) by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy.
Measured: 18 months
Secondary outcomes (13)
Major bleeding event (ISTH criteria)
Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ.
Measured: 3 months
PE-related death event
PE-related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer).
Measured: 3 months
A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria)
PE-related death event is defined as death due to a documented PE or unexplained death. Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ.
Measured: 3 months
Symptomatic VTE recurrence event
Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy.
Measured: 3 months
Hospitalization for VTE recurrence or clinically relevant bleeding events
Hospitalization for VTE recurrence or bleeding events. VTE recurrence event is defined as PE and/or DVT by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. Bleeding events are clinically relevant bleeding events, which is defined as major or clinically relevant non-major bleeding. Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ. Clinically relevant non-major bleeding event is defined as overt bleeding (i.e. is symptomatic or visualized by examination) which is not meeting the criteria for major bleeding, requires medical attention or is associated with discomfort for the subject such as pain, or impairment of activities of daily life.
Measured: 3 months
Major bleeding event (ISTH criteria)
Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ.
Measured: 18 months
PE-related death event
PE-related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer).
Measured: 18 months
Symptomatic VTE recurrence event
Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy.
Measured: 18 months
Clinically relevant non-major (CRNM) bleeding
A bleeding event will be classified as a clinically relevant non-major bleeding event if it is overt (i.e. is symptomatic or visualized by examination) not meeting the criteria for major bleeding, requires medical attention or is associated with discomfort for the subject such as pain, or impairment of activities of daily life.
Measured: 18 months
Clinically relevant bleeding
Clinically relevant bleeding is defined as major or CRNM bleeding.
Measured: 18 months
All-cause death
Death from any cause.
Measured: 18 months
Bleeding-related death event
Bleeding-related death event is defined as a bleeding event directly led to death. Examples of fatal bleeding events are an intracranial hemorrhage that led to herniation of the brain and death within 24 hours, and a massive gastrointestinal hemorrhage that results in shock, hemodynamic collapse, and death.
Measured: 18 months
Any adverse outcomes during invasive procedures
Adverse outcomes include bleeding events, recurrent VTE events, all-cause deaths.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start18 Feb 2021
- Primary completion27 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeshi Morimoto
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Yakuhin, Ltd.
- Responsible party
- Sponsor-investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, PhD, Principal investigator, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724460
- Sponsor's protocol ID
- Y0081
- Acronym
- ONCO PE
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2021
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagai T, Nakanishi N, Yamashita Y, Morimoto T, Hiramori S, Chatani R, Nishimoto Y, Ikeda N, Kobayashi Y, Ikeda S, Kim K, Shiba M, Takase T, Tsuji S, Oi M, Takada T, Otsui K, Sakamoto J, Ogihara Y, Inoue T, Usami S, Chen PM, Togi K, Koitabashi N, Doi K, Mabuchi H, Tsuyuki Y, Murata K, Takabayashi K, Nakai H, Sueta D, Shioyama W, Dohke T, Kimura T, Matoba S; COMMAND VTE Registry-2 Investigators. A Bleeding Risk Score for Cancer-Associated Venous Thromboembolism in Patients Receiving Direct Oral Anticoagulants. JACC CardioOncol. 2026 Jun;8(3):281-295. doi: 10.1016/j.jaccao.2026.05.002.
PubMed 42307155Xiong W, Yamashita Y, Morimoto T, Muraoka N, Shioyama W, Nakagawa Y, Chatani R, Yamamoto H, Shibata T, Morikawa N, Fukumoto Y, Nishimoto Y, Ono K, Kimura T; ONCO PE Trial Investigators. Extended Anticoagulation Therapy With Rivaroxaban for Cancer-Associated Low-Risk Pulmonary Embolism According to Different Performance Status Scores: Insights From the ONCO PE Randomized Trial. J Am Heart Assoc. 2026 Mar 17;15(6):e045541. doi: 10.1161/JAHA.125.045541. Epub 2026 Feb 27.
PubMed 41757461Yamashita Y, Morimoto T, Muraoka N, Shioyama W, Chatani R, Shibata T, Nishimoto Y, Ogihara Y, Doi K, Oi M, Shiga T, Sueta D, Kim K, Tanabe Y, Koitabashi N, Takada T, Ikeda S, Nakagawa H, Tsukahara K, Shoji M, Sakamoto J, Hisatake S, Ogino Y, Fujita M, Nakanishi N, Dohke T, Hiramori S, Nawada R, Kaneda K, Ono K, Kimura T; ONCO PE Trial Investigators. Rivaroxaban for 18 Months Versus 6 Months in Patients With Cancer and Acute Low-Risk Pulmonary Embolism: An Open-Label, Multicenter, Randomized Clinical Trial (ONCO PE Trial). Circulation. 2025 Mar 4;151(9):589-600. doi: 10.1161/CIRCULATIONAHA.124.072758. Epub 2024 Nov 18.
PubMed 39556015
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
- ClinicalTrials.gov ID
- NCT04724460
- Acronym / sponsor ID
- ONCO PE / Y0081
- Conditions
- Venous Thrombosis, Neoplasms, Anticoagulants
- Keywords
- Venous Thrombosis, Neoplasms, Anticoagulants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Takeshi MorimotoUniversity, hospital or other
- Collaborators
- Bayer Yakuhin, Ltd.
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jan 2021 (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.
The primary purpose of this study is to determine the optimal duration of anticoagulation therapy (6 months versus 18 months) with direct oral anticoagulant (DOAC) for cancer-associated low-risk pulmonary embolism patients. The major secondary purpose of this study is to investigate whether home treatment of cancer-associated low-risk pulmonary embolism patients with rivaroxaban is feasible, effective, and safe through an observational management study.
Detailed description
Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating VTE, although data on low-risk PE, including incidental PE and asymptomatic PE has been quite limited. However, low-risk PE was reported to account for a large proportion of all the diagnoses of PE detected on computed tomography in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines weakly suggest the same approach for low-risk PE patients with cancer as other PE patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that low-risk patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, the investigators randomly assign low-risk PE patients with active cancer to receive either rivaroxaban for 6 months (short DOAC group) or rivaroxaban for 18 months (long DOAC group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long DOAC | Active comparator | Drug: Long DOACAdministration of Rivaroxaban for 18 months |
| Short DOAC | Active comparator | Drug: Short DOACAdministration of Rivaroxaban for 6 months |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with active cancer (solid and hematologic malignancies) presenting with objectively newly confirmed pulmonary embolism who are scheduled to be treated by anticoagulation therapy.
- Patients with an simplified Pulmonary Embolism Severity Index (PESI) score of 1 or less
Key exclusion criteria (4 listed)
- Contraindicated patients for rivaroxaban (Clinically significant liver disease, Bacterial endocarditis, Active bleeding, Inadequate contraceptive measures if of childbearing potential, Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers or P-glycoprotein inhibitors or inducers)
- Expected life expectancy <6 months
- Patients who do not provide written informed consent
- Patients who judged to be inappropriate for enrolment by the physician (including patients at a high risk of gastrointestinal or genitourinary bleeding)
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 |
|---|---|---|
| Long DOACAdministration of Rivaroxaban for 18 months | Drug | Long DOAC |
| Short DOACAdministration of Rivaroxaban for 6 months | Drug | Short DOAC |
Primary outcome
VTE recurrence event Venous thromboembolism (VTE) recurrence event
Time frame: 18 months
VTE recurrence event is defined as pulmonary embolism (PE) and/or deep vein thrombosis (DVT) by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy.
13 secondary outcomes
Major bleeding event (ISTH criteria)
Time frame: 3 months
PE-related death event
Time frame: 3 months
A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria)
Time frame: 3 months
Symptomatic VTE recurrence event
Time frame: 3 months
Hospitalization for VTE recurrence or clinically relevant bleeding events
Time frame: 3 months
Major bleeding event (ISTH criteria)
Time frame: 18 months
PE-related death event
Time frame: 18 months
Symptomatic VTE recurrence event
Time frame: 18 months
Clinically relevant non-major (CRNM) bleeding
Time frame: 18 months
Clinically relevant bleeding
Time frame: 18 months
All-cause death
Time frame: 18 months
Bleeding-related death event
Time frame: 18 months
Any adverse outcomes during invasive procedures
Time frame: 18 months
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 11 Mar 2025.
- Derived from this study: PubMed 42307155Nagai T, Nakanishi N, Yamashita Y, Morimoto T, Hiramori S, Chatani R, Nishimoto Y, Ikeda N, Kobayashi Y, Ikeda S, Kim K, Shiba M, Takase T, Tsuji S, Oi M, Takada T, Otsui K, Sakamoto J, Ogihara Y, Inoue T, Usami S, Chen PM, Togi K, Koitabashi N, Doi K, Mabuchi H, Tsuyuki Y, Murata K, Takabayashi K, Nakai H, Sueta D, Shioyama W, Dohke T, Kimura T, Matoba S; COMMAND VTE Registry-2 Investigators. A Bleeding Risk Score for Cancer-Associated Venous Thromboembolism in Patients Receiving Direct Oral Anticoagulants. JACC CardioOncol. 2026 Jun;8(3):281-295. doi: 10.1016/j.jaccao.2026.05.002.
- Derived from this study: PubMed 41757461Xiong W, Yamashita Y, Morimoto T, Muraoka N, Shioyama W, Nakagawa Y, Chatani R, Yamamoto H, Shibata T, Morikawa N, Fukumoto Y, Nishimoto Y, Ono K, Kimura T; ONCO PE Trial Investigators. Extended Anticoagulation Therapy With Rivaroxaban for Cancer-Associated Low-Risk Pulmonary Embolism According to Different Performance Status Scores: Insights From the ONCO PE Randomized Trial. J Am Heart Assoc. 2026 Mar 17;15(6):e045541. doi: 10.1161/JAHA.125.045541. Epub 2026 Feb 27.
- Derived from this study: PubMed 39556015Yamashita Y, Morimoto T, Muraoka N, Shioyama W, Chatani R, Shibata T, Nishimoto Y, Ogihara Y, Doi K, Oi M, Shiga T, Sueta D, Kim K, Tanabe Y, Koitabashi N, Takada T, Ikeda S, Nakagawa H, Tsukahara K, Shoji M, Sakamoto J, Hisatake S, Ogino Y, Fujita M, Nakanishi N, Dohke T, Hiramori S, Nawada R, Kaneda K, Ono K, Kimura T; ONCO PE Trial Investigators. Rivaroxaban for 18 Months Versus 6 Months in Patients With Cancer and Acute Low-Risk Pulmonary Embolism: An Open-Label, Multicenter, Randomized Clinical Trial (ONCO PE Trial). Circulation. 2025 Mar 4;151(9):589-600. doi: 10.1161/CIRCULATIONAHA.124.072758. Epub 2024 Nov 18.
- 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.
Takeshi Kimura, MD, PhD principal investigator
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
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 Long DOAC and Short DOAC in people with Venous Thrombosis and Neoplasms, run by Takeshi Morimoto at 1 site in Japan.
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 2 inclusion and 4 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 11 Mar 2025. 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 Japan. 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?
VTE recurrence event Venous thromboembolism (VTE) recurrence event (time frame: 18 months). 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 NCT04724460, which also lists 3 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 11 Mar 2025.