None listed
Conditions
Interventions
Study medication, dosage and mode of administration
Ticagrelor monotherapy: ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily or corresponding placebo gi
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Sex/Gender
All
Age
40 Years to 95 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Men or women ≥40 years of age 3. Either acute ischaemic stroke or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms: Acute ischaemic stroke, defined as: • Neurological deficit attributed to the focal brain ischaemia, and either of the following: − Persistent signs or symptoms of the ischaemic event at the time of randomisation, OR − Acute, ischaemic brain lesion documented by computed tomography scan or magnetic resonance imaging (diffusion-weighted imaging) within 24 hours of onset of symptoms • National Institute of Health Stroke Score ≤5 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: − ABCD2 score ≥4 and TIA symptoms not limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo − Symptomatic intracranial arterial occlusive disease documented by transcranial doppler, ultrasound or vascular imaging, defined as at least 50% narrowing in diameter of a vessel that could account for the clinical presentation − Documented internal carotid arterial occlusive disease, defined as at least 50% narrowing in diameter of a vessel that could account for the clinical presentation 4. Head Computed Tomography (CT) or MRI ruling out haemorrhage or other pathology, such as vascular malformation, tumour, or abscess that could explain symptoms or contraindicate therapy
Exclusion criteria
Exclusion criteria: 1. Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins). In addition, patients receiving or requiring dual antiplatelet therapy with ASA and P2Y12 inhibitors will be excluded. 2. Known hypersensitivity to ticagrelor or ASA 3. Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke 4. Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation 5. Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation 6. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A (CYP3A) inhibitors or CYP3A substrates with narrow therapeutic indices that cannot be stopped for the course of the study − Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir − CYP3A substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily 7. Anticipated requirement for long-term (>7 days) non-steroidal anti-inflammatory drugs (NSAIDs) 8. Patients with known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura) 9. History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days 10. Known severe liver disease (eg, ascites or signs of coagulopathy) 11. Renal failure requiring dialysis 12. Pregnancy or lactation 13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 14. Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the Investigator 15. Previous enrolment or randomisation in the present study 16. Participation in another clinical study with an investigational product during the last 30 days
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Italy, Japan, Korea South, Mexico, Philippines, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States, Vietnam
Contacts
Public ContactUrsula Rodriguez Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed