StrokeNCT03266731
Role of Anti-platelet in Treatment of Acute Ischemic Stroke
A study testing Aspirin in people with Stroke, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2018to 4 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called clopidogrel
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
| Study group | Role | What they receive |
|---|---|---|
| use of aspirin and clopidogrel | Experimental | Not described Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start4 Jan 2018 (estimated)
- Primary completion4 Jan 2019 (estimated)
- Study completion4 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Tharwat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266731
- Sponsor's protocol ID
- ROAITOAIS
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anti-platelet in Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03266731
- Acronym / sponsor ID
- ROAITOAIS
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Jan 2018 (estimated)
- Primary completion
- 4 Jan 2019 (estimated)
- Study completion
- 4 Jan 2020 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| use of aspirin and clopidogrel | Experimental | Drug: Aspirin |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: clopidogrelevaluates 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 | Drug | use of aspirin and clopidogrel |
Primary outcome
A clinically significant neurologic deterioration
Time frame: 24 hours
NIHSS score to detect the outcome of the patients as a greater than or equal to 2-point decrease or a score of 0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Stroke, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hassan farweez, professor (01221741465, hassan.farwez@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A clinically significant neurologic deterioration (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.