Health Condition 1: G811- Spastic hemiplegia
Conditions
Interventions
Intervention1: Aspirin and Clopidogrel: Aspirin 75 mg and Clopidogrel 75 mg for a total of 12 months ( three months initially in both groups and then another 9 months in the intervention group)
Contro
Sponsors
Dr Rohit Bhatia
INSTRUCT Network
Eligibility
Inclusion criteria
Inclusion criteria: 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 >=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 ICA, intracranial VA, and Basilar artery. 4. Patients with a previous history of untreated stroke/TIA, at the discretion of the treating physician. 5. Patients with previous history of stroke/TIA and treated with antiplatelet therapy but has stopped the antiplatelet therapy for at least 3 months at the time of the current event and screening. 6. mRS upto 4 and below. 7. Informed consent. Exclusion criteria: 1. Stroke 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 ( >50%) of extracranial common carotid, internal carotid on ipsilateral side of current stroke. 7. Patients with asymptomatic stenosis ( >70%) of extracranial common carotid, internal carotid artery on contralateral side of current stroke. 8. Patients with moderate to severe extracranial stenosis ( >50%) of vertebral arteries. 9. Patients with intracranial arterial stenting. 10. Cardioembolic stroke. 11. 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. 12. Patients with Moya-Moya disease. 13. Patients with focal intracranial arterial dissection. 14. Any etiology other than atherosclerotic disease as the cause of intracranial arterial stenosis as perceived by the investigator. 15. Patients with intracranial vasculitis as the cause of intracranial vascular disease. 16. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. 17. Current use of oral anticoagulants. 18. Pregnancy 19. Hereditary or acquired hemorrhagic diathesis 20. Gastrointestinal or urinary bleeding within the preceding 21 days 21. Major surgery within the preceding 14 days. 22. Any comorbid serious illness which is likely to interfere with the treatment and /or life expectancy.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recurrent Ischemic stroke or TIA at the end of 12 months. 2. Any ICH, major or minor systemic bleeding at the end of 12 months 3. Safety outcomes: Any ICH, major or minor bleeding as defined using GUSTO classification at the end of 12 months and one month after completion of the drug treatment phase. Timepoint: 3, 6 and 9 months post randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of any stroke, MI or death at the end of 12 months. Any ICH, major or minor bleeding as defined using GUSTO classification one month after completion of the drug treatment phase. Timepoint: 3, 6, 9 months post-randomisation. | — |
Countries
India
Contacts
Public ContactDr Rohit Bhatia
AIIMS. New Delhi.
Outcome results
None listed