Clopidogrel for Acute Ischaemia of Recent Onset

NCT02776540 | Completed Phase 4 DMC

• 1 other identifier: CAIRORCT
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months

Secondary Outcomes (1)

• Bleeding complications of loading clopidogrel

  1 week

Study Arms (3)

900 mg Clopidogrel

ACTIVE COMPARATOR

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

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

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

Drug: Aspirin

Interventions

Clopidogrel DRUG

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

Also known as: Srtoka

600 mg Clopidogrel; 900 mg Clopidogrel

Aspirin DRUG

there's another group will receive 400 mg Aspirin

Also known as: Aspocid

400 mg Aspirin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ramez R Moustafa, MD PhD MRCP

  Department of Neurology, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Neurology

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 18, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

EG (1)