Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients with Cancer
- Conditions
- Pulmonary embolism
- Registration Number
- JPRN-jRCTs051200135
- Lead Sponsor
- Ono Koh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 330
1. Patients with active cancer (solid and hematologic malignancies) presenting with objectively newly confirmed PE who are scheduled to be treated by anticoagulation therapy.
2. Patients with an simplified PESI score of 1 or less
1. 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, etc)
2. Expected life expectancy <6 months
3. Patients who do not provide written informed consent.
4. Patients who judged to be inappropriate for enrolment by the physician (including patients at a high risk of gastrointestinal or genitourinary bleeding)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VTE recurrence event at 18 months
- Secondary Outcome Measures
Name Time Method Major bleeding event (ISTH criteria) at 18 months.<br>Clinically relevant non-major bleeding event at 18 months.<br>All bleeding event at 18 months<br>All-cause death at 18 months.<br>PE-related death at 18 months.<br>Bleeding-related death at 18 months<br>Symptomatic VTE recurrence event at 18 months.<br>Adverse event during invasive procedures at 18 months.<br>A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria) at 3 months.<br>PE-related death at 3 months.<br>Symptomatic VTE recurrence event at 3 months.<br>Major bleeding event (ISTH criteria) at 3 months.<br>VTE recurrence or bleeding events requiring hospitalization at 3 months