ClinicalTrials.gg
Status unknownNCT03266731Updated Aug 31, 2017

Role of Anti-platelet in Treatment of Acute Ischemic Stroke

An interventional study of Aspirin in Stroke, sponsored by Assiut University. Status unknown. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-31.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
40 Years and older
Sex
All
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Study 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.

Read the detailed description

In 2015, stroke was the second most frequent cause of death after coronary artery disease, accounting for 6.3 million deaths (11% of the total).Studies have reported a 30-day recurrence rate of 1.1 to 15 % after stroke and as high as 17% after transient ischemic attack .Therefore, early initiation of antiplatelet agents in ischemic stroke and patients is important to prevent stroke recurrence and is tracked as a quality measure by organizations that accredit stroke centers . Intravenous thrombolysis with alteplase is the mainstay medical treatment for acute ischemic stroke. given intravenously within 4.5 hours of symptom onset, to reopen occluded intracerebral arteries. As in fact most patients with ischemic stroke present to the emergency department beyond the approved time window for thrombolytic or other revascularization therapies beside their high cost and at this time, there are no approved urgent therapies for most of these patients In addition, those who present with rapidly resolving deficit or low National Institutes of Health stroke scale score are generally not considered for thrombolytic treatment, although approximately one third of them may be at high risk for neurological deterioration and recurrent vascular events.This study will evaluates the safety and efficacy of clopidogrel and aspirin in treatment of patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy with acute ischemic stroke and transient ischemic attack within 24 hours of symptoms onset.

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Conditions studied

  • Stroke

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03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 120 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Any history of ICH or systemic hemorrhage.
  2. Any evidence of hemorrhage on baseline CT brain imaging.
  3. Patients presented with failed medical or surgical thrombectomy.
  4. (INR) more than 1.5.
  5. History of allergy to aspirin or clopidogrel or both of them.
  6. count less than 100,000/mm3.
  7. Hematocrit less than 30 mg/dL .
  8. glucose less than 50 mg/dL or greater than 400 mg/dL.to exclude hypoglycemia induced focal neurological deficit.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    use of aspirin and clopidogrel

    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

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What researchers measure

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.

    Time frame: 24 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2018; primary completion for Jan 2019, 12 months later.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 12 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2017
First posted
Aug 30, 2017
StartEst.
Jan 4, 2018
Primary completionEst.
Jan 4, 2019
CompletionEst.
Jan 4, 2020
Last update
Aug 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03266731
Lead sponsor
Assiut University
Responsible party
Ahmed Tharwat (principal investigator, Assiut University) — Principal investigator
First posted
Aug 30, 2017
Start date
Jan 4, 2018 (estimated)
Primary completion
Jan 4, 2019 (estimated)
Completion
Jan 4, 2020 (estimated)
Last update
Aug 31, 2017

Study contacts

hassan farweez, professor
Contact
hassan.farwez@med.au.edu.eg
01221741465

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Aspirin

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