2023-508454-26-00招募中4 期
Randomized Multi-center Clinical Trial to Assess Effectiveness and Safety of Tirofiban Versus Intravenous Aspirin in Patients With Acute Ischemic Stroke Secondary to Tandem Injury, Subject to Recanalization Therapy Through Endovascular Treatment
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla13 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年4月30日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 13
- 主要终点
- Carotid Reocclusion
研究概览
简要总结
To assess the efficacy and safety of the use of tirofiban versus aspirin in patients with ischemic stroke secondary to tandem injury, by determining the rate of reocclusion as well as determining the rate of symptomatic bleeding defined as any hemorrhagic transformation associated with a worsening of 4 or more points on the National Institutes of Health Stroke Scale
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with acute ischemic stroke of the anterior territory secondary to a tandem lesion, with an indication for thrombectomy treatment according to the current recommendations of the Clinical Practice Guidelines, and the need for cervical stent placement.
- •The intracranial occlusion locations that may be included are: carotid "T", M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery; and in the case that the posterior cerebral artery has fetal origin and is the site of intracranial occlusion.
- •ASPECTS (Alberta Stroke Program Early computerized Tomography Score) ≥
- •Greater than or equal to 18 years of age.
- •Signed informed consent.
排除标准
- •Patients under 18 years of age.
- •Patients with intracranial occlusive arteriosclerotic disease or extra or intracranial dissection.
- •Documented allergy to acetylsalicylic acid or Tirofiban.
- •Personal history of platelet penia (Platelets <100,000)
- •Concomitant anticoagulant treatment (with presence of INR (International Normalized Ratio) > 1.7 in case of anti-vitamin K treatment or taking direct oral anticoagulant <48 hours ago)
- •Medical history of the patient that carries a high risk of bleeding according to the investigator's criteria.
- •Peptic ulcer active in the last 3 months.
- •Patients with ASPECTS <
- •Bilateral strokes or those produced by simultaneous occlusion of an artery in the anterior and posterior territory.
- •Patients whose carotid stenosis is due to a re-stenosis or reocclusion of a pre-existing cervical stent.
- •Candidate patients for carotid puncture.
- •Previous treatment with double antiplatelet therapy for another cause prior to inclusion.
- •Severe comorbidity and / or reduced life expectancy.
- •Modified Rankin scale (mRS)>
- •Severe allergy to contrast medium.
结局指标
主要结局
Carotid Reocclusion
Carotid Reocclusion
Platelet aggregation phenomena
Platelet aggregation phenomena
Symptomatic intracranial hemorrhage (sICH)
Symptomatic intracranial hemorrhage (sICH)
次要结局
- Good functional prognosis, Defined as a score on the modified rankin scale (mRS) between 0-2 at 90 days.
研究者
Clinical Trial Unit IBIS/University Hospital Virgen del Rocío
Scientific
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
研究点 (13)
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