Status:
COMPLETED
Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
Lead Sponsor:
Takeshi Morimoto
Collaborating Sponsors:
Bayer Yakuhin, Ltd.
Conditions:
Venous Thrombosis
Neoplasms
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 pulmo...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04724460
Start Date
February 18 2021
End Date
December 31 2024
Last Update
March 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto, Kyoto, Japan, 606-8507