Acute StrokePhase 3NCT03884530
Ticagrelol Versus Aspirin in Ischemic Stroke
A Phase 3 study testing Ticagrelor (Brilique) 90 and Aspirin 75mg in people with Acute Stroke and Ischemic Stroke, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
There is a debate whether ticagrelor is superior to aspirin in treating patients with ischemic stroke or not, most of the studies examine the effect of both drugs within 24 hours of acute stroke some find that there is no difference between ticagrelor and aspirin, others find that ticagrelor is superior to aspirin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Stroke, Ischemic Stroke
- What is being tested?
- Ticagrelor (Brilique) 90 and Aspirin 75mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 30 Sep 2020
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male \& female patients will be included
- Age between 18 - 75 years
- First ever presentation with acute ischemic stroke.Previous transient ischemic attacks (TIA's) are not excluding
- Ictus to drug time does not to exceed 9 hours.
Who cannot join
- Patient eligible for recombinant tissue plasminogen activator (rTPA)
- patients with( national institute of health stroke scale (NIHSS) below 3 or above 25
- patients with active malignancy
- patients with major surgery in past 3 months
- patients with known allergy to study drugs
- patients with acute myocardial infarction in past 6 months
Show all 14Show fewer
- patients known to suffer from multiple sclerosis or epilepsy
- pregnancy or lactation
- patients with history of head trauma with residual neurological deficits
- patients on regular ticagrelol in past week
- patients with international normalized ratio (INR) more than 1.3 or prothrombin time (PT) more than 18
- patients with venous thrombosis
- patients with platelet count less than 100000 or white blood cells (WBCs) less than 3000 or hematocrit value less than 0.25
- blood glucose less than 50 mg/DL or more than 400
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neuropsychiatry department Kafrelsheikh university hospital
Kafr ash Shaykh, 33511
About this study
There is a debate whether ticagrelor is superior to aspirin in treating patients with ischemic stroke or not, most of the studies examine the effect of both drugs within 24 hours of acute stroke some find that there is no difference between ticagrelor and aspirin, others find that ticagrelor is superior to aspirin.
At this study the investigators aim at evaluating the role of loading ticagrelor received within 9 hours of acute ischemic stroke in improving neurological outcome of stroke. And evaluating the risk of hemorrhagic and non- hemorrhagic complications associated with the use of ticagrelor180 ml oral loading dose within 9 hours acute ischemic stroke
Read the detailed description
ticagrelor is acyclo-pentyltriazolo-pyrimidine antiplatelet drug that inhibits the P2Y12which is a subtype of adenosine diphosphate (ADP)receptor.
It is a potent , direct-acting oral agent and it is reversibly binding P2Y12 receptors antagonist unlike the irreversible agents as clopidogrel, prasugrel, ticlopidine.
In 2011, the U.S. Food and Drug Administration (FDA) approved the blood-thinning drug (ticagrelor) to treat acute coronary syndromes, and in 2015, it approved it as long-term treatment in patient with history of heart attack.
In 2018, the American Heart Association ( AHA ) and American stroke Association (ASA) Guidelines for the Early Management of Patients with Acute Ischemic Stroke stated that, ticagrelor was not found to be superior to aspirin. However, because there were no significant safety differences, ticagrelor may be a reasonable alternative in stroke patients who have a contraindication to aspirin.
Aspirin overall reduces the risk of major vascular events by 13% Moreover, the risk of hemorrhagic events limits the use of aspirin in this setting, so the investigators aim at examining the hemorrhagic risks associated with use of loading Ticagrelor 180 ml within 9 hours of 1st ever acute ischemic stroke and compare the neurological outcomes in two groups of patients with 1st ever acute ischemic stroke receiving within 9 hours either Aspirin(300 mg (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that for 3 months and the other received 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose, and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours) for 3 months.
- Conditions
- Acute Stroke, Ischemic Stroke
- Being tested
- Ticagrelor (Brilique) 90, Aspirin 75mg
- Keywords
- ticagrelol, aspirin
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor (Brilique) 90Drug
Drug name Brilique 90 ml Drug form tablet
Aspirin 75mgDrug
Drug name Aspirin 75 ml Drug form tablet
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor ( Brilique) group | Active comparator | the group will receive 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose, and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours) for 3 months Receives: Drug: Ticagrelor (Brilique) 90 |
| Aspirin Group | Active comparator | The group will receive 300 mg Aspirin (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that for 3 months Receives: Drug: Aspirin 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group
hemorrhagic transformation detected by brain imaging CT and/or MRI brain will be done after 2 days of onset
Measured: 48 hours
amount of peripheral bleeding within 48 hours of loading anti platelet in each group
amount of peripheral bleeding measured in milliliter in each group
Measured: 48 hours
frequency of peripheral bleeding within 48 hours of loading anti platelet in each group
amount of peripheral bleeding measured as ( time per day )
Measured: 48 hours
Secondary outcomes (3)
difference between National institute of health stroke scale scores on admission and after one week in each group
National institute of health stroke scale ( NIHSS) difference between score on admission and after one week: we consider favorable outcome if there is decrease in NIHSS by 4 points or more this scale ranges from 0 to 42 . the higher the value the worse outcome with the following values: 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Measured: one week or discharge
Modified Rankin scale in each group
Modified Rankin Scale (MRS): assessed at the end of 3 months , the higher the value the worse the outcome , MRS has following values :
0 = No symptoms at all
- 1= No significant disability despite symptoms
- 2= Slight disability
- 3= Moderate disability
- 4= Moderately severe disability
- 5= Severe disability; bedridden
- 6= Dead we consider favorable mRS if it was 2 or less
Measured: after one week and after 3 months
Mortality in each group
Timing and cause of death will be assessed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 May 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into 2 groups. The first group formed of 85 patients will receive 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours). The second group formed of 84 patients will receive 300 mg Aspirin (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that. If the patients showed complications of the loading dose of ticagrelor (central or peripheral bleeding the dose will be minimized to 90 mg (1 tablet of 90 mg).
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Mohamed zeinhom Gomaa, Kafrelsheikh University
- Investigators
- Hani Mohamed M Aref, MD, Study chair, neuropsychiatry department Ain shams faculty of medicineHala M Elkhawas, MD, Study director, neuropsychiatry department Ain shams faculty of medicineAhmed I Elbassiouny, MD, Study director, neuropsychiatry department Ain shams faculty of medicineTamer M Roushdy, MD, Study director, neuropsychiatry department Ain shams faculty of medicineHossam S Mohammed, MD, Study director, neuropsychiatry department Ain shams faculty of medicineMohamed Zeinhom M Gomaa, M.Sc., Principal investigator, neuropsychiatry department Kafrelsheikh faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884530
- Sponsor's protocol ID
- 2388
- Status last verified
- Aug 2021
- First submitted
- 8 Mar 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the individual participant data for all primary and secondary outcomes measures will be made available
Publications
Johnston SC, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KS; SOCRATES Steering Committee and Investigators. Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Jul 7;375(1):35-43. doi: 10.1056/NEJMoa1603060. Epub 2016 May 10.
PubMed 27160892Aref HM, El-Khawas H, Elbassiouny A, Shokri HM, Zeinhom MG, Roushdy TM. A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke. Neurol Sci. 2023 Feb;44(2):765-771. doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30.
PubMed 36446950Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30.
PubMed 34515113
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelol Versus Aspirin in Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03884530
- Acronym / sponsor ID
- 2388
- Conditions
- Acute Stroke, Ischemic Stroke
- Keywords
- ticagrelol, aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 21 Mar 2019 (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.
There is a debate whether ticagrelor is superior to aspirin in treating patients with ischemic stroke or not, most of the studies examine the effect of both drugs within 24 hours of acute stroke some find that there is no difference between ticagrelor and aspirin, others find that ticagrelor is superior to aspirin.
At this study the investigators aim at evaluating the role of loading ticagrelor received within 9 hours of acute ischemic stroke in improving neurological outcome of stroke. And evaluating the risk of hemorrhagic and non- hemorrhagic complications associated with the use of ticagrelor180 ml oral loading dose within 9 hours acute ischemic stroke
Detailed description
ticagrelor is acyclo-pentyltriazolo-pyrimidine antiplatelet drug that inhibits the P2Y12which is a subtype of adenosine diphosphate (ADP)receptor.
It is a potent , direct-acting oral agent and it is reversibly binding P2Y12 receptors antagonist unlike the irreversible agents as clopidogrel, prasugrel, ticlopidine.
In 2011, the U.S. Food and Drug Administration (FDA) approved the blood-thinning drug (ticagrelor) to treat acute coronary syndromes, and in 2015, it approved it as long-term treatment in patient with history of heart attack.
In 2018, the American Heart Association ( AHA ) and American stroke Association (ASA) Guidelines for the Early Management of Patients with Acute Ischemic Stroke stated that, ticagrelor was not found to be superior to aspirin. However, because there were no significant safety differences, ticagrelor may be a reasonable alternative in stroke patients who have a contraindication to aspirin.
Aspirin overall reduces the risk of major vascular events by 13% Moreover, the risk of hemorrhagic events limits the use of aspirin in this setting, so the investigators aim at examining the hemorrhagic risks associated with use of loading Ticagrelor 180 ml within 9 hours of 1st ever acute ischemic stroke and compare the neurological outcomes in two groups of patients with 1st ever acute ischemic stroke receiving within 9 hours either Aspirin(300 mg (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that for 3 months and the other received 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose, and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours) for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be divided into 2 groups. The first group formed of 85 patients will receive 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours). The second group formed of 84 patients will receive 300 mg Aspirin (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that. If the patients showed complications of the loading dose of ticagrelor (central or peripheral bleeding the dose will be minimized to 90 mg (1 tablet of 90 mg).
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor ( Brilique) group | Active comparator | Drug: Ticagrelor (Brilique) 90the group will receive 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose, and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours) for 3 months |
| Aspirin Group | Active comparator | Drug: Aspirin 75mgThe group will receive 300 mg Aspirin (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male \& female patients will be included
- Age between 18 - 75 years
- First ever presentation with acute ischemic stroke.Previous transient ischemic attacks (TIA's) are not excluding
- Ictus to drug time does not to exceed 9 hours.
Key exclusion criteria (14 listed)
- Patient eligible for recombinant tissue plasminogen activator (rTPA)
- patients with( national institute of health stroke scale (NIHSS) below 3 or above 25
- patients with active malignancy
- patients with major surgery in past 3 months
- patients with known allergy to study drugs
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 |
|---|---|---|
| Ticagrelor (Brilique) 90Drug name Brilique 90 ml Drug form tablet | Drug | Ticagrelor ( Brilique) group |
| Aspirin 75mgDrug name Aspirin 75 ml Drug form tablet | Drug | Aspirin Group |
Primary outcome
hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group
Time frame: 48 hours
hemorrhagic transformation detected by brain imaging CT and/or MRI brain will be done after 2 days of onset
amount of peripheral bleeding within 48 hours of loading anti platelet in each group
Time frame: 48 hours
amount of peripheral bleeding measured in milliliter in each group
frequency of peripheral bleeding within 48 hours of loading anti platelet in each group
Time frame: 48 hours
amount of peripheral bleeding measured as ( time per day )
3 secondary outcomes
difference between National institute of health stroke scale scores on admission and after one week in each group
Time frame: one week or discharge
Modified Rankin scale in each group
Time frame: after one week and after 3 months
Mortality in each group
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Results publication: PubMed 27160892Johnston SC, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KS; SOCRATES Steering Committee and Investigators. Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Jul 7;375(1):35-43. doi: 10.1056/NEJMoa1603060. Epub 2016 May 10.
- Derived from this study: PubMed 36446950Aref HM, El-Khawas H, Elbassiouny A, Shokri HM, Zeinhom MG, Roushdy TM. A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke. Neurol Sci. 2023 Feb;44(2):765-771. doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30.
- Derived from this study: PubMed 34515113Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30.
- https://www.ncbi.nlm.nih.gov/pubmed/27160892Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. the individual participant data for all primary and secondary outcomes measures will be made available
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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.
Hani Mohamed M Aref, MD study chair
neuropsychiatry department Ain shams faculty of medicine
Hala M Elkhawas, MD study director
neuropsychiatry department Ain shams faculty of medicine
Ahmed I Elbassiouny, MD study director
neuropsychiatry department Ain shams faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor (Brilique) 90 and Aspirin 75mg in people with Acute Stroke and Ischemic Stroke, run by Kafrelsheikh University at 1 site in Egypt.
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 14 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: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884530, which also lists 3 linked publications.
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 2 Sep 2021; AzTrials last refreshed its copy on 2 Nov 2026.