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| Name | Class |
|---|---|
| Ain Shams University | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor (Brilique) 90 | Drug | Drug name Brilique 90 ml Drug form tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 ) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hani Mohamed M Aref, MD | neuropsychiatry department Ain shams faculty of medicine | Study Chair |
| Hala M Elkhawas, MD | neuropsychiatry department Ain shams faculty of medicine | Study Director |
| Ahmed I Elbassiouny, MD | neuropsychiatry department Ain shams faculty of medicine | Study Director |
| Tamer M Roushdy, MD | neuropsychiatry department Ain shams faculty of medicine | Study Director |
| Hossam S Mohammed, MD | neuropsychiatry department Ain shams faculty of medicine | Study Director |
| Mohamed Zeinhom M Gomaa, M.Sc. | neuropsychiatry department Kafrelsheikh faculty of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatry department Kafrelsheikh university hospital | Kafr ash Shaykh | 33511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27160892 | Result | 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. | |
| 36446950 |
| Label | URL |
|---|---|
| https://www.ncbi.nlm.nih.gov/pubmed/27160892 | View source |
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the individual participant data for all primary and secondary outcomes measures will be made available
data will be available after 6 months of study completion
data access requests will be reviewed by an external independent review panel , requestors will be required to sign a data access agreement
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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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).
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| Aspirin 75mg |
| Drug |
Drug name Aspirin 75 ml Drug form tablet |
|
| 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
| after one week and after 3 months |
| Mortality in each group | Timing and cause of death will be assessed | 3 months |
| Aref 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. |
| 34515113 | Derived | Zeinhom 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |