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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 900 mg Clopidogrel | Active Comparator | 67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient |
|
| 600 mg Clopidogrel | Active Comparator | 67 patient will receive 8 tablets clopidogrel (each 75 mg) as total 600 mg each patient and 4 tablets placebo to receive 12 tablets as total |
|
| 400 mg Aspirin | Placebo Comparator | 67 patients will receive 4 tablets Aspirin ( each 75 mg) as total 300 mg for each patient and 8 tablets placebo to receive 12 tablets as total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of NIH stroke scale score | Patients will be assessed for early neurologic improvement or deterioration using the change of NIH stroke scale score. Early neurological outcome | Baseline and up to 1 week |
| Neurologic outcome | patients will be assessed for neurologic outcome using the Modified Ranking Scale at 3 months after onset | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding complications of loading clopidogrel | will follow cerebral bleeding complications using CT scan, and systemic bleeding complications (GI bleeding, hematuria, etc.) that may occur following the loading dose | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
Patients eligible for intravenous (recombinant tissue plasminogen activator) rTPA thrombolysis or thrombectomy.
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.
Clinical seizures at the onset of stroke.
Patients with known history or manifestations of any major organ failure.
Patients who have had acute myocardial infarction within 1 month; and/or with management interfering with the current study (e.g. warfarin).
Patients with active malignancies, and/or have been on chemo- or radiotherapy within the last year.
Patients with active peptic ulcer and/or (gastrointestinal tract) GIT surgery or bleeding within the last year.
Persistent uncontrolled vomiting during the first day of admission.
Patients with major surgery within the last 3 months.
Patients with history of uncontrolled bleeding site, within the prior year.
Patients with known allergy to study drugs.
Patients with known history of persistent or recurrent (central nervous system) CNS pathology (e.g. epilepsies, meningioma, multiple sclerosis).
Patients with past history of head trauma with residual neurological deficit
Patients who are on regular Clopidogrel during the week before admission.
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).
Patients who have an indication for full anti-coagulation during the first week of their hospital stay will be retrospectively excluded.
Patients receiving anti-coagulants in deep venous thrombosis (DVT) prophylaxis doses will NOT be excluded:
Pregnancy or breast feeding
Stroke due to venous thrombosis
Hemorrhagic stroke
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
Arterial puncture in a non-compressible site within the previous week
Strokes following cardiac arrest or profuse hypotension.
Blood glucose level < 50 or > 400 mg/dl on admission
CBC with picture of severe anemia (Haematocrit <0.25), thrombocytopenia (Platelets < 100,000) or leucopenia (WBC < 3,000).
Significant electrolyte imbalance that may account for the presenting manifestations
Contraindications to imaging
Urgent brain CT revealing any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Ramez R Moustafa, MD PhD MRCP | Department of Neurology, Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | 11566 | Egypt |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| Aspirin | Drug | there's another group will receive 400 mg Aspirin |
|
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |