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临床试验/CTRI/2022/01/039445
CTRI/2022/01/039445招募中3 期

ongterm Single versus Dual Antiplatelet Therapy In Patients With Ischemic Stroke due to Intracranial Atherosclerotic Disease: A Randomized Trial. - STENOSIS

Dr Rohit Bhatia0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Age 18 years and above.
  • 2.Patients with an acute ischemic stroke, OR a recent AIS OR TIA within 3 months from onset AND who have been started on DAPT with aspirin and clopidogrel within 15 days of the stroke/TIA onset and have been compliant on treatment and yet to complete 3 months of DAPT. All patients need to be on DAPT with aspirin and clopidogrel for 3 months at the time of randomization.
  • 3.Symptomatic ICAD greater than or equal to 50% in intracranial vessels on CT Angiogram or contrast MR angiogram, or Digital Subtraction Angiography including M1 MCA, M2 MCA, ACA A1 , PCA P1, intracranial VA and Basilar artery.
  • 4.mRS upto 4.
  • 5.Informed consent.
  • 6. Patients with a previous history of untreated stroke/TIA, at the discretion of the treating

排除标准

  • 1.Stroke/ TIA more than 3 months at time of presentation.
  • 2.Not started on DAPT with aspirin and clopidogrel within 15 days of stroke/ TIA onset.
  • 3.Patients with an intracerebral hemorrhage.
  • 4.Indication for DAPT other than the current stroke/ TIA; for example, patient with CAD and Post PTCA.
  • 5.Patients with recurrent stroke/TIA, on treatment following the initial event.
  • 6.Patients with moderate to severe tandem stenosis of extracranial common carotid, internal carotid or vertebral arteries.
  • 7.Patients with intracranial arterial stenting.
  • 8.Cardioembolic stroke.
  • 9.Patient with a known autoimmune disease or any other immunological disease that may be interfering with the interpretation and cause of etiology of intracranial stenosis.
  • 10.Patients with Moya-Moya disease.
  • 11.Patients with focal intracranial arterial dissection.
  • 12.Any etiology other than atherosclerotic disease as the cause of intracranial arterial stenosis as perceived by the investigator.
  • 13.Patients with intracranial vasculitis as the cause of intracranial vascular disease.
  • 14.Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
  • 15. Current use of oral anticoagulants.
  • 16.Pregnancy
  • 17.Hereditary or acquired hemorrhagic diathesis
  • 18.Gastrointestinal or urinary bleeding within the preceding 21 days
  • 19.Major surgery within the preceding 14 days.
  • 20.Any comorbid serious illness which is likely to interfere with the treatment and /or life expectancy.
  • 21.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.
  • 22.Any modification of treatment judged during the course of the trial, which is likely to interfere with the continuation of the medications and results of the study.

研究者

发起方
Dr Rohit Bhatia

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