A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack
A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack
Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events
Inclusion Criteria:
Provision of signed informed consent prior to any study-specific procedure
≥40 years of age
Acute onset of cerebral ischaemia due to
AIS with NIHSS ≤5. AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, and either of the following:
High-risk TIA, defined as neurological deficit of acute onset attributed to focal ischaemia of the brain by history or examination with complete resolution of the deficit, and at least one of the following:
Randomisation occurring within 24 hours after onset of symptoms; for wake-up strokes (when the time of symptom onset is not known), within 24 hours from the time point at which the patient was reported to be in their normal condition
CT or MRI performed after symptom onset ruling out intracranial haemorrhage or other pathology, such as vascular malformation, tumour, or abscess that according
to the Investigator could explain symptoms or contraindicate study treatment
Exclusion Criteria:
Need for or an anticipated need for any of the following:
Any history of atrial fibrillation/flutter, ventricular aneurysm, or suspicion of other cardioembolic pathology for TIA or stroke
Patients who should receive or have received any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation
Planned carotid endarterectomy that requires halting investigational product within 3 days of randomisation or is expected to require unblinding of investigational product (planned carotid endarterectomy is in itself not an exclusion criterion)
History of previous intracranial haemorrhage at any time (asymptomatic microbleeds do not qualify), gastrointestinal haemorrhage within the past 6 months, or major surgery within 30 days
Patients considered to be at risk of bradycardic events (eg, known sick sinus syndrome or second- or third-degree atrioventricular block) unless already treated with a permanent pacemaker
Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the Investigator
Known hypersensitivity to ticagrelor or ASA
Need for or an anticipated need for oral or intravenous therapy with any of the following:
Known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
Known severe liver disease (eg, ascites or signs of coagulopathy)
Renal failure requiring dialysis
Pregnancy or breastfeeding. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Previous enrolment or randomisation in the present study
Participation in another clinical study with an investigational product at any time during the 30 days prior to randomisation (regardless of when treatment with the investigational product was discontinued)
Capital Federal, 1428, Argentina
Ciudad Autónoma de Bs. As., C1199ABB, Argentina
Saint-Priez En Jarez, 42270, France
Sopron-Balf, 9494, Hungary
D.F, 14269, Mexico
Urb. El Chipe, 20007, Peru
Jeju-do, 63241, South Korea
Taoyuan Hsien, 33305, Taiwan
Muang, 57000, Thailand
Nakhonpathom, 73000, Thailand
Prachinburi, 25000, Thailand
Rajthevi, 10400, Thailand
Ubonratchathani, 34000, Thailand
Chernivtsі, 58001, Ukraine
Kharkiv Region, 61018, Ukraine
Kharkiv Region, 61176, Ukraine