Clopidogrel for Acute Ischaemia of Recent Onset

Phase 4

Completed

• Conditions: Ischemic Cerebrovascular Accident
• Interventions: Drug: Clopidogrel; Drug: Aspirin

• Registration Number: NCT02776540
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Start: 2016-06-01
• Status Verified: 2019-02
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
900 mg Clopidogrel	Clopidogrel	67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient
600 mg Clopidogrel	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
400 mg Aspirin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt