Impact of Apixaban on portal venous thrombosis in cirrhosis: A randomised controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of patients with partial or complete recanalization of portal venous thrombosis
研究概览
简要总结
Studies have observed that traditional anticoagulants (warfarin and low molecular weight heparin) are safe and effective in the treatment of portal vein thrombosis in cirrhotic patients. Recent studies in patients suffering from cardiac diseases have shown better efficacy and lesser side effects of newer direct oral anticoagulants like apixaban compared to traditional anticoagulants in cirrhosis. But there is dearth of studies evaluating the efficacy and safety of the newer anticoagulants in recanalization of portal venous thrombosis in patients with cirrhosis. Therefore, we plan to conduct this study to assess the impact of apixaban in recanalisation of portal venous thrombosis and other clinically significant outcomes like hepatic decompensation in cirrhotic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults more than or equal to 18 years B.
- •Patients diagnosed with cirrhosis based on clinical and/or laboratory criteria, ultrasound/fibroscan/liver biopsy.
- •Thrombosis in portal venous system D.
- •Written informed consent.
排除标准
- •Hepatic venous outflow tract obstruction
- •Triple positive antiphospholipid antibody syndrome
- •Hepatocellular or malignant neoplasia at the time of inclusion
- •Active bleeding from any site (e.g., active variceal bleeding)
- •High risk varices at the time of inclusion
- •Hypersensitivity to active ingredients or excipients
- •Pregnancy and lactation
- •Any comorbidity involving therapeutic limitation and/or life expectancy less than 12 months
- •Renal impairment (creatinine clearance less than 15 ml/min or on hemodialysis)
- •HE grades 2 or higher
- •Severe thrombocytopenia less than 20k/mm3
- •Potent dual inhibitors of CYP3A4 and P-gp, (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin) or dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort)
- •Coadministration of antiplatelet drugs.
结局指标
主要结局
Proportion of patients with partial or complete recanalization of portal venous thrombosis
时间窗: 12 months
次要结局
- Incidence of adverse events-major and minor bleed(12 months)
- Proportion of patients with progression of portal venous thrombosis(12 months)
- Predictors of recanalization of thrombosis
- Frequency of individual and composite of liver-related events (ascites, hepatic encephalopathy, variceal bleeding, ACLF and HCC)(12 months)
- Change in CTP, MELD and non-invasive liver fibrosis score(12 months)
研究者
Dr Shalimar
All India Institute of Medical Sciences, New Delhi