Clopidogrel for Acute Ischaemia of Recent Onset (CAIRO)

February 10, 2019 updated by: Eman Mones Abushady, Ain Shams University

Clopidogrel Loading for Acute Ischaemia of Recent Onset (CAIRO)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and up to 1 week
Neurologic outcome
Time Frame: 3 months
patients will be assessed for neurologic outcome using the Modified Ranking Scale at 3 months after onset
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ramez R Moustafa, MD PhD MRCP, Department of Neurology, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAIRORCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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