NCT04724460

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

3.6 years

First QC Date

January 22, 2021

Last Update Submit

March 8, 2025

Conditions

Venous ThrombosisNeoplasmsAnticoagulants

Keywords

Venous ThrombosisNeoplasmsAnticoagulants

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Secondary Outcomes (13)

  • Major bleeding event (ISTH criteria)

    3 months

  • PE-related death event

    3 months

  • A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria)

    3 months

  • Symptomatic VTE recurrence event

    3 months

  • Hospitalization for VTE recurrence or clinically relevant bleeding events

    3 months

  • +8 more secondary outcomes

Study Arms (2)

Long DOAC

ACTIVE COMPARATOR

Administration of Rivaroxaban for 18 months

Drug: Long DOAC

Short DOAC

ACTIVE COMPARATOR

Administration of Rivaroxaban for 6 months

Drug: Short DOAC

Interventions

Long DOACDRUG

Administration of Rivaroxaban for 18 months

Long DOAC
Short DOACDRUG

Administration of Rivaroxaban for 6 months

Short DOAC

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Kyoto, Kyoto, 606-8507, Japan

Location

Related Publications (1)

  • Yamashita 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: 39556015DERIVED

MeSH Terms

Conditions

Venous ThrombosisNeoplasms

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Takeshi Kimura, MD, PhD

    Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Statistician

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 26, 2021

Study Start

February 18, 2021

Primary Completion

September 27, 2024

Study Completion

December 31, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)