Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer

Y0081

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.

2021-02-18

2024-09-30

2024-12-31

Active (not recruiting)

Early phase I

177

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 177, 'type': 'ACTUAL'}}

2023-04-04