Abelacimab versus apixaban in the treatment of cancer associated VTE

Phase 3

Recruiting

• Conditions: Cancer associatated thrombosis

• Registration Number: JPRN-jRCT2041230073
• Lead Sponsor: Hara Yochiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Adult male or female subjects are eligible for study participation if they have confirmed (histology, adequate imaging modality) diagnosis of cancer (other than basal-cell or squamous cell carcinoma of the skin) and presentation with acute VTE, for which long-term treatment with DOACs is indicated. The key eligibility criteria include (all the following must be met at the screening and randomization visits):
- Male or female subjects >=18 years old or another legal maturity age according to the country of residence
- Confirmed diagnosis of cancer (by histology or adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following:
- Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or
- Currently receiving or having received anticancer therapy(radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
- Confirmed symptomatic or incidental proximal lower limb DVT (i.e.,popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic PE, or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 72 hours from diagnosis of the qualifying VTE.

Exclusion Criteria

'-Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
- More than 72 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants
-An indication to continue treatment with therapeutic doses of an anticoagulant other than that used for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
-Platelet count <50,000/mm3 at the screening visit
-PE leading to hemodynamic instability (systolic blood pressure [BP] <90 mmHg or shock)
-Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4 weeks preceding screening
-Brain trauma, or a cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia in the 4 weeks preceding screening
-Need for aspirin in a dosage of more than 100 mg/per day or any other antiplatelet agent alone or in combination with aspirin
-Primary brain cancer or untreated intracranial metastases
-Acute myeloid or lymphoid leukemia
-Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
-Planned major surgery at baseline
-Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
-Life expectancy <3 months at randomization
-Calculated creatinine clearance (CrCl) <30 mL/min at the screening visit
-Hemoglobin less than 8 g/dL at the screening visit
-Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range at the screening visit in absence of clinical explanation
-Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)

Study & Design

• Study Type: Interventional
• Study Design: Not specified