A Pilot Trial of Restarting Direct Oral Anticoagulants After Traumatic Intracranial Hemorrhage
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 主要终点
- 60-day composite endpoint
研究概览
简要总结
Randomized pilot trial of restarting DOACs at 1 week versus 4 weeks after traumatic intracranial hemorrhage
详细描述
Restart TICrH two-center pilot trial will assign patients with anticoagulant-associated traumatic intracranial hemorrhage to restart anticoagulation at 1 week or 4 weeks. Entry into the trial is primarily driven pragmatically by clinician intent to restart any Direct Oral Anticoagulant (DOAC, i.e. apixaban, rivaroxaban, edoxaban, dabigatran. There is no head to head evidence of superiority of any drug) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. DOAC will be at label dose with label adjustments for creatinine clearance. DOAC will be at continuation dose, i.e. not initial therapy high doses in the setting of VTE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Central blinded assessment of endpoints
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE)
- •Patient is higher risk for stroke or other thrombotic events as witnessed by having a CHA2DS2-VASc score of > 3 (at least 3 of the following risk factors: age greater than 65, (age > 75 counts for 2 points), history of stroke or TIA (2 points), history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female biological sex, history of hypertension)
- •DOAC prescribed at label dose with creatinine clearance adjustments. DOAC at continuation dose, i.e., not initial therapy high doses in the setting of VTE
排除标准
- •Mechanical Valve or Ventricular Assist Device (VAD)
- •SDH >8 mm maximum width or any midline shift at any time point or more than one SDH
- •Physician plan to start/restart antiplatelet therapy during trial period
- •Abbreviated Injury Scale other than head >3
- •Inability to understand need for adherence to study protocol
- •Renal function below DOAC label exclusions
- •Any active pathological bleeding (e.g. no acute blood on most recent CT)
- •Hypersensitivity to drug or other label contraindication
- •Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks
- •Completion of DOAC therapy expected prior to 60 day primary endpoint, e.g. 3-6 month VTE treatment
- •Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
- •Low body weight (<45kg)
- •Inability to swallow
研究组 & 干预措施
1 week restart
restart DOAC at 1 week post injury at label dose and frequency
干预措施: Apixaban (Drug)
4 week restart
restart DOAC at 4 weeks post injury at label dose and frequency
干预措施: Apixaban (Drug)
结局指标
主要结局
60-day composite endpoint
时间窗: 60 days
A 60-day composite endpoint that includes the following clinical events: New or expansion of intracranial hemorrhage, other BARC3a or above major hemorrhage 28, stroke, systemic embolism, myocardial infarction, proximal lower extremity deep vein thrombosis, pulmonary embolism and cardiovascular death
次要结局
- Disability Rating Scale (0-29 scale range)(60 days)
- Modified Rankin Scale (0-6 scale range)(60 day)
- Standard Gamble(pre-randomization (The day before randomization, which must occur within 6 days of index injury) and after endpoints (the day after one of the endpoints occurs. We cannot know precisely when this will occur in the 60 day follow up period))
研究者
Truman J Milling Jr
Research Director SDMS Stroke Institute
University of Texas at Austin