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

JRCT ID: jRCTs051200135

Registered date:16/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary embolism
• Date of first enrollment: 17/02/2021
• Target sample size: 330
• Study type: Interventional
• Intervention(s): 6 months of Rivaroxaban treatment group (Short DOAC group) and 18 months of Rivaroxaban treatment group (Long DOAC group)

Outcome(s)

• Primary Outcome: VTE recurrence event at 18 months

Secondary Outcome

Major bleeding event (ISTH criteria) at 18 months.
Clinically relevant non-major bleeding event at 18 months.
All bleeding event at 18 months
All-cause death at 18 months.
PE-related death at 18 months.
Bleeding-related death at 18 months
Symptomatic VTE recurrence event at 18 months.
Adverse event during invasive procedures at 18 months.
A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria) at 3 months.
PE-related death at 3 months.
Symptomatic VTE recurrence event at 3 months.
Major bleeding event (ISTH criteria) at 3 months.
VTE recurrence or bleeding events requiring hospitalization at 3 months

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

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

Exclude criteria

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)

Related Information

• Primary Sponsor: Ono Koh
• Source(s) of Monetary Support: Bayer
• Secondary ID(s): NCT04724460