Dabigatran Versus Apixaban in Cerebral Venous Thrombosis, a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The proportion of subjects who have partial or complete venous recanalization by Day 180
研究概览
简要总结
Along with the current clinical trial, the efficacy and safety of a 150 mg Bid dabigatran administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to apixaban 5mg Bid were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral hemorrhagic complications
详细描述
The investigators conducted a single-blinded randomized controlled trial between August 2021 and August 2024 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it.
The investigators got written informed consent from all eligible patients or their first order of kin before randomization.
The study will be composed of 2 arms Dabigatran arm, which consisted of 100 patients who received 150 mg Bid dabigatran daily for 6 months, and the apixaban arm, consisting of 100 patients who received (5 mg Bid for 6 months),
Study Procedures:
Every patient in our study will undergo:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
An independent statistician generated a blocked randomization sequence using computer-generated random numbers; in a one-to-one ratio, participants were randomly assigned to receive doses of Dabigatran or rivaroxaban by a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 580 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 580. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened, and the patients were assigned to receive drugs A or B. Drug A included dabigatran, and Drug B included apixaban. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and above
- •New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram
- •Ability to randomize within 14 days of neuroimaging-confirmed diagnosis
- •The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care
- •The patient or legally authorized representative can give written informed consent
排除标准
- •The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis
- •The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) before initiation of oral anticoagulation
- •Patient is unable to swallow due to a depressed level of consciousness
- •Impaired renal function (i.e., CrCl < 30 mL/min using CockroftGault equation)
- •Pregnancy: if a woman is of childbearing potential, a urine or serum beta-human chorionic gonadotropin (β-hCG) test is positive
- •Breastfeeding at the time of randomization
- •Bleeding diathesis or other contraindication to anticoagulation
- •Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
- •Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of Dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)
- •The patient has a severe or fatal comorbid illness that will prevent improvement
研究组 & 干预措施
Dabigatran
100 CVT patients will receive dabigatran 150mg Bid for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire
干预措施: Dabigatran Etexilate 150mg (Drug)
apixaban
100 CVT patients will receive apixaban 5mg Bid for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire
干预措施: Apixaban 5MG (Drug)
结局指标
主要结局
The proportion of subjects who have partial or complete venous recanalization by Day 180
时间窗: 180 days
The investigators will perform magnetic resonance venography for all patients after 6 months to show if there is partial or complete recanalization of the affected venous sinus
Rate of drug-related hemorrhagic complications
时间窗: 180 days
the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin \> 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites.
次要结局
- value of HIT-6 score in each group after six months of treatment(6 months)
- value of Modified Rankin Scale (mRS) at six months(6 months)
- rate of drug adverse effects(6 months)
- The proportion of participants with recurrent venous thromboembolism(6 months)
- rate of composite pulmonary embolism, myocardial infarction, and death due to vascular events(6 months)
研究者
Mohamed G. zeinhom, MD
principal investigator
Kafrelsheikh University