(22138) A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of BAY 3018250 in patients with symptomatic proximal deep vein thrombosis - 22138

Bayer AG0 个研究点目标入组 255 人开始时间: 2023年7月18日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Male and female (if postmenopausal or hysterectomized) aged 18 years or older, Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following: a. duration of symptoms 14 days or less b. Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein c. adequate visualization of the most proximal end of the thrombus d. receiving therapeutic dose anticoagulation with LMWHs and/or DOACs according to the respective product labels, Measured body weight within 50 to 130 kg, Signed informed consent

•Acute symptomatic PE requiring systemic or catheter-directed thrombolytic therapy, catheter-directed mechanical thrombectomy, or surgical embolectomy, Active bleeding or high risk for bleeding (at the discretion of the investigator), Recent (<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage, or major surgery or severe trauma (at the discretion of the investigator), Active cancer, i.e., locally active, regionally invasive or metastatic and/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma, Therapeutic-dose anticoagulants for > 72 hours before randomization, or current use of vitamin K antagonists, Planned or current use of the following medications: Planned or current use of the following medications: a. Any antiplatelet therapy, except ASA =100 mg/day, b. Antifibrinolytic drugs, c.Therapeutic antibodies, Male participants with WOCBP partners unwilling to use highly effective contraception from start of study intervention until end of study.

发起方