NCT07134738已完成不适用
Multicenter, Open-label, Non-interventional Study to Assess the Safety and Tolerability of Dimolegin® as a Means of Preventing Thrombotic Complications in the Complex Therapy of Hospitalized Patients With Moderate COVID-19 in a Real Clinical Practice
Avexima Diol LLC6 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2024年6月7日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 6
- 主要终点
- Frequency of major bleeding events
研究概览
简要总结
A multicenter, open-label, non-interventional study evaluates the safety and tolerability of oral Dimolegin® (60 mg once daily) for thromboprophylaxis in hospitalized adults (≥18 years) with moderate COVID-19 in real clinical pratice. The primary objective is to assess safety and tolerability of Dimolegin® in preventing thrombotic complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Here's a concise English translation:
- •Voluntarily signed informed consent to participate in a non-interventional study.
- •Hospitalized patients with moderate COVID-19 requiring anticoagulant therapy for prevention of thrombotic complications.
- •Men and women aged ≥18 years.
- •Patients prescribed Dimolegin® 10 mg enteric-coated film tablets for thromboprophylaxis as part of routine care for moderate COVID-
- •Ability to understand study requirements, provide written consent and comply with protocol procedures.
排除标准
- •Hypersensitivity to Dimolegin®.
- •Clinically significant active bleeding at screening.
- •Concomitant therapy with fibrinolytics or other anticoagulants.
- •Anemia or thrombocytopenia.
- •Thrombophilia.
- •Other coagulopathies or contraindications to anticoagulants.
- •Liver disease with impaired function or biliary tract disease.
- •Creatinine clearance <30 mL/min.
- •Gastrointestinal disorders affecting absorption.
- •Pregnancy, breastfeeding, suspected pregnancy, or planned pregnancy within 3 months (including male patients whose partners plan pregnancy).
- •Use of investigational or unapproved drugs, or participation in another clinical study within 90 days before therapy start.
- •History or suspicion of alcohol or drug abuse, dependence, or addiction.
- •Any other condition that, in the investigator's opinion, could interfere with study participation or pose undue risk.
研究组 & 干预措施
1 (Dimolegin® Group)
Dimolegin® is administered orally once dailyюThe recommended dose is 60 mg once daily. Treatment duration depends on clinical indication and may last up to 30 days.
干预措施: Dimolegin (Drug)
结局指标
主要结局
Frequency of major bleeding events
时间窗: through discharge from the hospital, up to 30 days
次要结局
- Frequency of major bleeding events(up to 60±3 days)
- Frequency of moderate bleeding events(up to 60±3 days)
- Frequency of minor bleeding events(up to 60±3 days)
- Frequency of anemia(up to 60±3 days)
- Frequency of AR of special interest regardless of severity(up to 60±3 days)
- Proportion of patients with ARs and SARs(up to 60±3 days)
- Change from baseline in INR, APTT, prothrombin time, and D-dimer levels(through discharge from the hospital, up to 30 days)
- Frequency of gastrointestinal symptoms(through discharge from the hospital, up to 30 days)
研究者
研究点 (6)
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