Cervical Artery Dissection in Stroke Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
研究概览
简要总结
This is a feasibility study to determine if a sufficient number of patients can be recruited throughout the United Kingdom and whether sufficient endpoints can be generated for a full scale therapeutic trial of anticoagulants versus antiplatelets in acute cervical artery dissection treatment.
详细描述
ST. GEORGE'S HEADED NOTEPAPER
CADISS FEASIBILITY STUDY (Cervical Artery Dissection in Stroke Study) PROTOCOL
Aim:
To determine the feasibility of a clinical trial comparing antiplatelet therapy with anticoagulation in the acute treatment of patients with cervical artery dissection. Specifically to address whether:
- There are sufficient clinical endpoints to provide the power to determine treatment effect;
- Adequate numbers of patients can be recruited.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extracranial carotid or vertebral artery dissection with symptom onset within the last 7 days. This includes:
- •Ipsilateral transient ischemic attack or stroke
- •Ipsilateral Horner's syndrome or neck pain with known date of onset.
- •Imaging evidence of definite or probable dissection on MRI/MRA, CTA or ultrasound.
排除标准
- •Intracranial cerebral artery dissection
- •Symptom onset after 7 days
- •Contraindication to either antiplatelet agents or anticoagulation therapy
- •Patient's refusal to consent
- •Patients who are undergoing angiography and stenting or surgery for treatment of their dissection.
研究组 & 干预措施
Anti-platelet therapy
Aspirin, Dipyridamole, clopidogrel alone or in dual therapy
干预措施: Antiplatelet (Aspirin, Dipyridamole, clopidogrel) (Drug)
Anti-coagulant
Warfarin, unfractionated heparin, enoxaparin, dalteparin, tinzaparin aiming for an INR in range of 2-3. Local protocols for Heparin can be used
干预措施: Anticoagulant (Unfractionated Heparin, LMW Heparin, Warfarin) (Drug)