Basilar Artery International Cooperation Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 282
- 试验地点
- 36
- 主要终点
- Favourable outcome
研究概览
简要总结
Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.
Objective: Evaluate the efficacy and safety of IAT in addition to best medical management (BMM) in patients with basilar artery occlusion.
Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.
Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar occlusion.
Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone. IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.
Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Best medical management.
Best medical management consists of the standard of care of patients with acute ischemic stroke according to existing local protocols and guidelines, and may include IV thrombolysis.
If treated with IVT as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.
Additional intra-arterial treatment.
Best medical management followed by intra-arterial treatment and best medical management
干预措施: Intra-arterial treatment (Other)
结局指标
主要结局
Favourable outcome
时间窗: day 90
Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
次要结局
- Excellent outcome(day 90)
- Modified Rankin Score(day 90)
- NIHSS(pre IVT, pre randomization, 24h post treatment)
- EQ-5D(day 90 and 12 months)
研究者
Erik van der Hoeven
E.J.R.J. van der Hoeven, MD
St. Antonius Hospital