PER-081-13已完成未知
A RANDOMISED, DOUBLE-BLIND, MULTINATIONAL STUDY TO PREVENT MAJOR VASCULAR EVENTS WITH TICAGRELOR COMPARED TO ASPIRIN (ASA) IN PATIENTS WITH ACUTE ISCHAEMIC STROKE OR TIA[SOCRATES –ACUTE STROKE OR TRANSIENT ISCHAEMIC ATTACK TREATED WITH ASPIRIN OR TICAGRELOR AND PATIENT OUTCOMES]
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 至 95（—）
- 性别
- All
入选标准
- •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
- •− Persistent signs or symptoms of the ischaemic event at the time of
- •randomisation,
- •− 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
排除标准
- •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
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