A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

Anthos Therapeutics, Inc.0 个研究点目标入组 66 人开始时间: 2024年1月11日最近更新: 2024年12月6日

试验速览

阶段: 不适用
状态: 招募中
发起方: Anthos Therapeutics, Inc.
入组人数: 66
主要终点: Recurrent VTE

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Prevention Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•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 120 hours from diagnosis of the qualifying VTE.

排除标准

•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 120 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 brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
•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)

结局指标

主要结局

Recurrent VTE

Recurrent VTE is either: - Confirmed new symptomatic or incidental proximal DVT of the legs, iliac veins and/or inferior vena cava - Confirmed new symptomatic PE - Confirmed new incidental PE located in segmental or more proximal arteries - Fatal PE (including unexplained death for which PE cannot be ruled out)

次要结局

未报告次要终点

研究者

发起方

Anthos Therapeutics, Inc.

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