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Clopidogrel for Acute Ischaemia of Recent Onset (CAIRO)

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ClinicalTrials.gov Identifier: NCT02776540
Recruitment Status : Completed
First Posted : May 18, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Mones Abushady, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Ischemic Cerebrovascular Accident Drug: Clopidogrel Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clopidogrel Loading for Acute Ischaemia of Recent Onset (CAIRO)
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 900 mg Clopidogrel
67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient
Drug: Clopidogrel
there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel
Other Name: Srtoka

Active Comparator: 600 mg Clopidogrel
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
Drug: Clopidogrel
there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel
Other Name: Srtoka

Placebo Comparator: 400 mg Aspirin
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
Drug: Aspirin
there's another group will receive 400 mg Aspirin
Other Name: Aspocid




Primary Outcome Measures :
  1. The change of NIH stroke scale score [ Time Frame: 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

  2. Neurologic outcome [ Time Frame: 3 months ]
    patients will be assessed for neurologic outcome using the Modified Ranking Scale at 3 months after onset


Secondary Outcome Measures :
  1. Bleeding complications of loading clopidogrel [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776540


Locations
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Egypt
Ain Shams University Hospitals
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ramez R Moustafa, MD PhD MRCP Department of Neurology, Ain Shams University

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Responsible Party: Eman Mones Abushady, Assistant Lecturer of Neurology, Ain Shams University
ClinicalTrials.gov Identifier: NCT02776540     History of Changes
Other Study ID Numbers: CAIRORCT
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Stroke
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents