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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

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 18, 2016
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • 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
  • Neurologic outcome [ Time Frame: 3 months ]
    patients will be assessed for neurologic outcome using the Modified Ranking Scale at 3 months after onset
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02776540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clopidogrel for Acute Ischaemia of Recent Onset
Official Title  ICMJE Clopidogrel Loading for Acute Ischaemia of Recent Onset (CAIRO)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Cerebrovascular Accident
Intervention  ICMJE
  • Drug: Clopidogrel
    there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel
    Other Name: Srtoka
  • Drug: Aspirin
    there's another group will receive 400 mg Aspirin
    Other Name: Aspocid
Study Arms  ICMJE
  • Active Comparator: 900 mg Clopidogrel
    67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient
    Intervention: Drug: Clopidogrel
  • 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
    Intervention: Drug: Clopidogrel
  • 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
    Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2019)
188
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)
201
Actual Study Completion Date  ICMJE February 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02776540
Other Study ID Numbers  ICMJE CAIRORCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eman Mones Abushady, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ramez R Moustafa, MD PhD MRCP Department of Neurology, Ain Shams University
PRS Account Ain Shams University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP