Clinical trial NCT04724460: Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
Official title: Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thrombosis
Neoplasms
Anticoagulants
Keywords: Venous Thrombosis
Neoplasms
Anticoagulants
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Bayer Yakuhin, Ltd.
First posted: 2021-01-26
Enrollment: 179
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 data on low-risk PE, including incidental PE and asymptomatic PE has been quite limited. However, low-risk PE was reported to account for a large proportion of all the diagnoses of PE detected on computed tomography in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines weakly suggest the same approach for low-risk PE patients with cancer as other PE patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that low-risk patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, the investigators randomly assign low-risk PE patients with active cancer to receive either rivaroxaban for 6 months (short DOAC group) or rivaroxaban for 18 months (long DOAC group).

Eligibility criteria: 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)

Primary outcomes:
measure: VTE recurrence event Venous thromboembolism (VTE) recurrence event
timeFrame: 18 months
Secondary outcomes:
measure: Major bleeding event (ISTH criteria)
timeFrame: 3 months
measure: PE-related death event
timeFrame: 3 months
measure: A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria)
timeFrame: 3 months
measure: Symptomatic VTE recurrence event
timeFrame: 3 months
measure: Hospitalization for VTE recurrence or clinically relevant bleeding events
timeFrame: 3 months
measure: Major bleeding event (ISTH criteria)
timeFrame: 18 months
measure: PE-related death event
timeFrame: 18 months
measure: Symptomatic VTE recurrence event
timeFrame: 18 months
measure: Clinically relevant non-major (CRNM) bleeding
timeFrame: 18 months
measure: Clinically relevant bleeding
timeFrame: 18 months
measure: All-cause death
timeFrame: 18 months
measure: Bleeding-related death event
timeFrame: 18 months
measure: Any adverse outcomes during invasive procedures
timeFrame: 18 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Study officials:
affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: