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OpenTrials
Completed

NCT Number: NCT02776540

Clopidogrel for Acute Ischaemia of Recent Onset

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, 11566, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel

Drug

there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel

Other names: Srtoka

Aspirin

Drug

there's another group will receive 400 mg Aspirin

Other names: Aspocid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Clopidogrel Loading for Acute Ischaemia of Recent Onset (CAIRO)

Acronym: CAIRO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 18, 2016
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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