Ticagrelol Versus Aspirin in Ischemic Stroke
Condition: Acute Stroke; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

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.

      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.
    

Intervention name(s): Ticagrelor (Brilique) 90; Aspirin 75mg
Intervention type(s): Drug; Drug
Intervention description(s): Drug name Brilique 90 ml Drug form tablet; Drug name Aspirin 75 ml Drug form tablet
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: ticagrelol; aspirin