A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 主要终点
- Major Vascular Occlusive events
研究概览
简要总结
A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.
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
Blinded assessment and adjudication 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 either mono or dual antiplatelet therapy
- •History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet *Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement).
排除标准
- •SDH >8 mm maximum width or any midline shift at any time point or more than one SDH
- •Physician plan to start/restart anticoagulant therapy during trial period
- •Abbreviated Injury Scale other than head >3
- •Inability to understand need for adherence to study protocol
- •Any active pathological bleeding (no acute blood on most recent CT)
- •Hypersensitivity to drug or other label contraindication
- •Any bleeding that the investigator deems unsafe to restart at 1 week post injury
- •Inability to swallow
结局指标
主要结局
Major Vascular Occlusive events
时间窗: Baseline (gambles performed pre-randomization)
Ischemic stroke; myocardial infarction; mesenteric ischemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; and carotid, coronary, or peripheral arterial revascularization procedures. Major vascular events defined by the Antithrombotic Trialists' Collaboration
major bleeding
时间窗: 60 days
Recurrent ICrH or other major bleeding defined by BARC3A
次要结局
未报告次要终点
研究者
Truman J Milling Jr
Research Director SDMS Stroke Institute
University of Texas at Austin