NCT03354429已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 11,016
- 试验地点
- 1
- 主要终点
- Composite of Subsequent Stroke or Death
研究概览
简要总结
Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, and either of the following:
- •Persistent signs or symptoms of the ischaemic event at the time o randomisation, OR
- •Acute ischaemic brain lesion documented before randomisation by computed tomography (CT) scan or magnetic resonance imaging (MRI) (diffusion-weighted imaging) and that could account for the clinical presentation
- •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 ≥6 and TIA symptoms not limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo
- •Symptomatic intracranial arterial occlusive disease that could account for the clinical presentation, documented by transcranial Doppler or vascular imaging and defined as at least 50% narrowing in the diameter of the vessel lumen
- •Internal carotid arterial occlusive disease that could account for the clinical presentation, documented by Doppler, ultrasound, or vascular imaging and defined as at least 50% narrowing in diameter of the vessel lumen
- •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
排除标准
- •Need for or an anticipated need for any of the following:
- •Dual antiplatelet therapy with ASA and P2Y12 inhibitors (including patients with carotid artery stenting and percutaneous coronary intervention)
- •Antiplatelets other than ASA (eg, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol, ticagrelor) and other antithrombotic agents with antiplatelet effects, including traditional/herbal medicine agents
- •Anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, fondaparinux, or unfractionated heparin and long-term treatment with low-molecular weight heparins). Short-term treatment (≤7 days) with low-dose low-molecular weight heparin may be used in immobilised patients at the discretion of the Investigator
- •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:
- •Strong cytochrome P450 3A (CYP3A4) inhibitors (eg, ketoconazole, clarithromycin [but not erythromycin or azithromycin], nefazadone, ritonavir, atazanavir) that cannot be stopped for the course of the study
- •Long-term (>7 days) non-steroidal anti-inflammatory drugs
- •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)
研究组 & 干预措施
TICAGRELOR
Experimental
干预措施: Ticagrelor (Drug)
TICAGRELOR PLACEBO
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Composite of Subsequent Stroke or Death
时间窗: From randomisation (day 1) to visit 3 (day 30-34)
Participants with subsequent stroke or death
次要结局
- Ischaemic Stroke(From randomisation (day 1) to visit 3 (day 30-34))
- Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3(Visit 3 (day 30-34))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01991795AstraZeneca19,271
Unknown
2 期
TIMES: Ticagrelor vs. Placebo/ Clopidogrel With Aspirin in Anterior STEMI Patients Treated With Primary PCIST Elevation Myocardial InfarctionNCT03145194Papworth Hospital NHS Foundation Trust140
已完成
3 期
Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of AspirinCardiovascular DeathAtherothrombosisStrokeMyocardial InfarctionNCT01225562AstraZeneca21,379
终止
3 期
Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell DiseaseSickle Cell DiseaseNCT03615924AstraZeneca193
终止
3 期
Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABGAcute Coronary SyndromeStable AnginaCoronary Artery DiseaseNCT01755520Deutsches Herzzentrum Muenchen1,893