Ischemic Cerebrovascular AccidentPhase 4CAIRONCT02776540
Clopidogrel for Acute Ischaemia of Recent Onset
A Phase 4 study testing Clopidogrel and Aspirin in people with Ischemic Cerebrovascular Accident, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Cerebrovascular Accident
- What is being tested?
- Clopidogrel and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2016to 1 Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ischemic Cerebrovascular Accident
- Being tested
- Clopidogrel, Aspirin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Srtoka
there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel
AspirinDrug
Also called Aspocid
there's another group will receive 400 mg Aspirin
| Study group | Role | What they receive |
|---|---|---|
| 900 mg Clopidogrel | Active comparator | 67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient Receives: Drug: Clopidogrel |
| 600 mg Clopidogrel | Active comparator | 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 Receives: Drug: Clopidogrel |
| 400 mg Aspirin | Placebo comparator | 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 Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of NIH stroke scale score
Patients will be assessed for early neurologic improvement or deterioration using the change of NIH stroke scale score. Early neurological outcome
Measured: Baseline and up to 1 week
Neurologic outcome
patients will be assessed for neurologic outcome using the Modified Ranking Scale at 3 months after onset
Measured: 3 months
Secondary outcomes (1)
Bleeding complications of loading clopidogrel
will follow cerebral bleeding complications using CT scan, and systemic bleeding complications (GI bleeding, hematuria, etc.) that may occur following the loading dose
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mones Abushady, Ain Shams University
- Investigators
- Ramez R Moustafa, MD PhD MRCP, Principal investigator, Department of Neurology, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776540
- Sponsor's protocol ID
- CAIRORCT
- Acronym
- CAIRO
- Status last verified
- Feb 2019
- First submitted
- 2 May 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel Loading for Acute Ischaemia of Recent Onset (CAIRO)
- ClinicalTrials.gov ID
- NCT02776540
- Acronym / sponsor ID
- CAIRO / CAIRORCT
- Conditions
- Ischemic Cerebrovascular Accident
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 900 mg Clopidogrel | Active comparator | Drug: Clopidogrel67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient |
| 600 mg Clopidogrel | Active comparator | Drug: Clopidogrel67 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 |
| 400 mg Aspirin | Placebo comparator | Drug: Aspirin67 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (36 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelAlso: Srtokathere is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel | Drug | 600 mg Clopidogrel, 900 mg Clopidogrel |
| AspirinAlso: Aspocidthere's another group will receive 400 mg Aspirin | Drug | 400 mg Aspirin |
Primary outcome
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
1 secondary outcome
Bleeding complications of loading clopidogrel
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramez R Moustafa, MD PhD MRCP principal investigator
Department of Neurology, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Aspirin in people with Ischemic Cerebrovascular Accident, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of NIH stroke scale score (time frame: Baseline and up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.