Clopidogrel for Acute Ischaemia of Recent Onset

NCT ID: NCT02776540

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-02-01

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.

Conditions

Ischemic Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

900 mg Clopidogrel

67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Aspirin

Intervention Type: DRUG

there's another group will receive 400 mg Aspirin

Interventions

Clopidogrel

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

Intervention Type: DRUG

Aspirin

there's another group will receive 400 mg Aspirin

Intervention Type: DRUG

Other Intervention Names

Srtoka; Aspocid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Eman Mones Abushady

Assistant Lecturer of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramez R Moustafa, MD PhD MRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CAIRORCT

Identifier Type: -

Identifier Source: org_study_id