Canadian Pradaxa Acute Stroke Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Symptomatic Hemorrhagic Transformation Rate (PH2)
研究概览
简要总结
Study Design:
This is a multicentre, prospective, open-label, single arm, phase IV registry study. No additional procedures are included in the study. Standard clinical data will be collected. This will include a physical examination and NIHSS score assessment at baseline. In addition, all neuro-imaging will be collected. Standard imaging includes a non-contrast CT brain at baseline and 7±2 days post-treatment. Repeat NIHSS score assessment at the time of the 7 day CT scan. Repeat clinical and NIHSS score assessment 30 days post-enrolment will also be collected when performed as part of standard care.
Study Objectives:
- Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in patients with atrial fibrillation.
- Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of dabigatran treatment following stroke/TIA
- Determine the effect of asymptomatic hemorrhagic transformation on functional and neurological outcome at 30 days.
详细描述
Study Aim and Design:
The primary aim of the CPASS registry is to demonstrate the safety of early anticoagulation with dabigatran following cardioembolic stroke. CPASS is a prospective open label single arm observational study. Safety will be established by demonstrating low rates of hemorrhage in this setting.
Administrative Structure:
CPASS is a Canadian Stroke Consortium led study. The study coordinating centre is at the University of Alberta. Case report forms and data monitoring will be completed electronically, using an online EDC system. All imaging data will be read centrally at the Stroke Imaging Laboratory at the University of Alberta.
Study Design Considerations:
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
- •All patients will be ≥ 18 years of age.
- •Minor ischemic stroke, defined as NIHSS score ≤
- •Transient Ischemic Attack (TIA), defined as acute focal neurological deficits, with complete resolution of symptoms within 24 h of onset. In cases where onset time cannot be established, it will be considered to be the time when the patient was last known to be well.
- •Atrial Fibrillation (AF, paroxysmal or persistent). AF must be confirmed with ECG/Holter monitor, or by history All patients prescribed dabigatran according to the Canadian product label by the treating physician following their stroke/TIA. The decision to treat with dabigatran and the timing of the first dose will be determined by the attending physician, independent of the registry. All patients will have a CT scan or MRI, with findings consistent with an ischemic etiology of symptoms.
- •Ability to obtain informed consent obtained from patient or legally authorized representative.
排除标准
- •Acute or chronic renal failure, defined as eGFR <30 ml/min (Cockcroft Gault formula).
- •Known hypersensitivity to dabigatran or any other contraindication to dabigatran therapy, as per Canadian label information.
- •Prior treatment with dabigatran or any other novel oral anticoagulant (including all Factor Xa antagonists). Treatment with warfarin prior to the stroke/TIA is acceptable, but enrolment cannot begin until the INR is ≤1.
- •Prior symptomatic ischemic stroke (TIA is not an exclusion criterion)
- •Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent major surgery.
- •Clinically significant recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
- •Hereditary or acquired hemorrhagic diathesis.
- •Anticipated inability to comply with follow up.
- •Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
结局指标
主要结局
Symptomatic Hemorrhagic Transformation Rate (PH2)
时间窗: 30 days post-treatment
Symptomatic Hemorrhagic Transformation Rate (PH2) associated with clinical deterioration, defined as worsening of NIHSS score of 4 or more points within 30 days of initiating dabigatran therapy.
次要结局
- Any Parenchymal Haemorrhage (PH1 or PH2)(7 days post-enrollment)
- Symptomatic Hemorrhagic Transformation Rate(30 days post enrolment)
- Recurrent TIA/Ischemic Stroke(30 days post enrolment)
- Systemic Hemorrhagic Complication Rate(30 days post enrolment)