Clinical trial · Interventional
Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
NCT04724460CI-TRIAL-00087026ONCO PEcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anticoagulants | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Venous Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Long DOAC | Drug | — | UNRESOLVED |
| Short DOAC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Long DOAC
- description
- Administration of Rivaroxaban for 18 months
- interventionNames
- Drug: Long DOAC
- type
- ACTIVE_COMPARATOR
- label
- Short DOAC
- description
- Administration of Rivaroxaban for 6 months
- interventionNames
- Drug: Short DOAC
Primary outcomes (1)
- measure
- VTE recurrence event Venous thromboembolism (VTE) recurrence event
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (3)
- DERIVEDNagai 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. PMID 42307155
- DERIVEDXiong 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. PMID 41757461
- DERIVEDYamashita 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. PMID 39556015