Ischemic Cerebrovascular Accident
Conditions
Brief summary
Evaluate the role of loading Clopidogrel in acute ischemic stroke in improving neurological outcome of stroke in cases patients will be non-eligible for, or declined, treatment with or intravenous thrombolysis with rTPA, rTPA is not available or thrombectomy.
Interventions
DRUGClopidogrel
there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel
DRUGAspirin
there's another group will receive 400 mg Aspirin
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. First ever presentation with acute ischemic stroke. Previous transient ischemic attacks (TIA's) are not excluding, regardless of their frequency or severity 2. Ictus to drug time does not to exceed 9 hours (allowing for at least 30 minutes to obtain imaging) 3. Patients with undetermined time of onset will be included only if they were last seen well within the same time window (9hrs). Onset of events in patients presented with stuttering stroke will be considered from the onset of the first clinical manifestation. 4. According to National Institute of Health Stroke Scale (NIHSS) on admission, patient will be recruited with NIHSS between 4 and 24 (both inclusive).
Exclusion criteria
1. Patients eligible for intravenous (recombinant tissue plasminogen activator) rTPA thrombolysis or thrombectomy. 2. If NIHSS on admission is 3 or less, 25 or more, or patients who are showing rapidly resolving symptoms prior to the results of imaging. 3. Clinical seizures at the onset of stroke. 4. Patients with known history or manifestations of any major organ failure. 5. Patients who have had acute myocardial infarction within 1 month; and/or with management interfering with the current study (e.g. warfarin). 6. Patients with active malignancies, and/or have been on chemo- or radiotherapy within the last year. 7. Patients with active peptic ulcer and/or (gastrointestinal tract) GIT surgery or bleeding within the last year. 8. Persistent uncontrolled vomiting during the first day of admission. 9. Patients with major surgery within the last 3 months. 10. Patients with history of uncontrolled bleeding site, within the prior year. 11. Patients with known allergy to study drugs. 12. Patients with known history of persistent or recurrent (central nervous system) CNS pathology (e.g. epilepsies, meningioma, multiple sclerosis). 13. Patients with past history of head trauma with residual neurological deficit 14. Patients who are on regular Clopidogrel during the week before admission. 15. Patient with raised prothrombin time (PT) on admission, either on anticoagulants (with raised INR\>1.3, PT \>18 second) or not (PT\> 15 second), or on drugs that might increase possibility of peripheral bleeding (e.g. corticosteroids). 16. Patients who have an indication for full anti-coagulation during the first week of their hospital stay will be retrospectively excluded. 17. Patients receiving anti-coagulants in deep venous thrombosis (DVT) prophylaxis doses will NOT be excluded: * Enoxaparin 40mg/d (or equivalent). * Heparin with partial thromboplastin time (PTT) not exceeding 50 seconds. * Oral anticoagulation with INR \<1.5. 18. Pregnancy or breast feeding 19. Stroke due to venous thrombosis 20. Hemorrhagic stroke 21. Blood pressure \< 90/60 or \> 185/110 mmHg, if not responding to intravenous antihypertensive therapy or requiring aggressive treatment to reduce it below this limit 22. Arterial puncture in a non-compressible site within the previous week 23. Strokes following cardiac arrest or profuse hypotension. 24. Blood glucose level \< 50 or \> 400 mg/dl on admission 25. CBC with picture of severe anemia (Haematocrit \<0.25), thrombocytopenia (Platelets \< 100,000) or leucopenia (WBC \< 3,000). 26. Significant electrolyte imbalance that may account for the presenting manifestations 27. Contraindications to imaging 28. Urgent brain CT revealing any of the following: * Hemorrhage. * Major cerebral non-vascular pathology. * Suspected arterio-venous malformation (AVM). * Previous intracerebral hemorrhage or old infarctions larger than 1.5 cm. * Massive acute hypo density in the brain region corresponding to the current symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of NIH stroke scale score | Baseline and up to 1 week | Patients will be assessed for early neurologic improvement or deterioration using the change of NIH stroke scale score. Early neurological outcome |
| Neurologic outcome | 3 months | patients will be assessed for neurologic outcome using the Modified Ranking Scale at 3 months after onset |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding complications of loading clopidogrel | 1 week | will follow cerebral bleeding complications using CT scan, and systemic bleeding complications (GI bleeding, hematuria, etc.) that may occur following the loading dose |
Countries
Egypt
Outcome results
None listed