CAIRO: Clopidogrel for Acute Ischaemia of Recent Onset

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02776540

Collaborator

(none)

188

Enrollment

Location

Arms

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jun 1, 2016

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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 Names: 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 Names: 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 Names: Aspocid

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 Names:

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 Names:

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 Names:

Aspocid

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First ever presentation with acute ischemic stroke. Previous transient ischemic attacks (TIA's) are not excluding, regardless of their frequency or severity
Ictus to drug time does not to exceed 9 hours (allowing for at least 30 minutes to obtain imaging)
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.
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:

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:

Enoxaparin 40mg/d (or equivalent).
Heparin with partial thromboplastin time (PTT) not exceeding 50 seconds.
Oral anticoagulation with INR <1.5.

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo		Egypt	11566

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Ramez R Moustafa, MD PhD MRCP, Department of Neurology, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Mones Abushady, Assistant Lecturer of Neurology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT02776540

Other Study ID Numbers:

CAIRORCT

First Posted:

May 18, 2016

Last Update Posted:

Feb 12, 2019

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2019