NCT03266731

Brief Summary

Role of anti-platelet in treatment of acute ischemic stroke to determine the safety of immediate anti-platelet therapy .that is started as soon as possible within the first 24 hours of the onset of symptoms.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable stroke

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2020

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 28, 2017

Last Update Submit

August 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • A clinically significant neurologic deterioration

    NIHSS score to detect the outcome of the patients as a greater than or equal to 2-point decrease or a score of 0.

    24 hours

Study Arms (1)

use of aspirin and clopidogrel

EXPERIMENTAL
Drug: Aspirin

Interventions

evaluates the safety and efficacy of clopidogrel and aspirin as an alternative treatment in patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy with acute ischemic stroke (AIS) and transient ischemic attack (TIA) within 24 hours of symptoms onset

Also known as: clopidogrel
use of aspirin and clopidogrel

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of the patients is 40 years or older.
  • Patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy presenting after 6hours of onset of symptoms.
  • Patients presented with clinical symptoms of acute stroke or TIA with onset less than 24 hours before starting any treatment.
  • The diagnosis of stroke or TIA basing on clinical examination using National Institute of Health stroke scale (NIHSS) by a stroke specialist

You may not qualify if:

  • Any history of ICH or systemic hemorrhage.
  • Any evidence of hemorrhage on baseline CT brain imaging.
  • Patients presented with failed medical or surgical thrombectomy.
  • International normalized ratio (INR) more than 1.5.
  • History of allergy to aspirin or clopidogrel or both of them.
  • Platelets count less than 100,000/mm3.
  • Hematocrit less than 30 mg/dL .
  • glucose less than 50 mg/dL or greater than 400 mg/dL.to exclude hypoglycemia induced focal neurological deficit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

hassan farweez, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

January 4, 2018

Primary Completion

January 4, 2019

Study Completion

January 4, 2020

Last Updated

August 31, 2017

Record last verified: 2017-08