EUCTR2009-017242-30-IT进行中（未招募）不适用
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction - PEGUSUS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 21,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Men and women >50 years of age. 2.Documented history of presumed spontaneous MI (excluding known peri-procedural or definite secondary MI [eg, due to profound hypotension, hypertensive emergency, tachycardia, or profound anemia]) with their most recent MI occurring 1 to 3 years prior to randomization and have at least 1 of the following risk factors: -Age =65 years -Diabetes mellitus requiring medication -Documented history of a second prior presumed spontaneous MI (>1 year ago) -Angiographic evidence of multivessel coronary artery disease (CAD) (stenoses =50% in two major coronary artery territories [ie, left anterior descending, ramus intermedius, left circumflex, right coronary artery] involving the main vessel, a major branch, or a bypass graft). -Chronic, non-end stage renal dysfunction (creatinine clearance calculated by Cockcroft Gault equation <60 mL/min) . 3.Patient currently prescribed and tolerating ASA, and able to be prescribed the protocol mandated dose of 75 - 150 mg once daily for the duration of the study. 4.Females of child-bearing potential (ie, who are not chemically or surgically sterilized or who are not post-menopause) must have a negative urine pregnancy test at enrollment (to be confirmed by blood pregnancy test at the central lab.) Females of child-bearing potential must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator. 5.Written informed consent prior to any study specific procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Planned use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole, or cilostazol 2.Planned coronary, cerebrovascular, or peripheral arterial revascularization 3.Concomitant oral or intravenous therapy with strong cytochrome P450 3A (CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which 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, over 1 litre daily of grapefruit juice -Substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily -Strong inducers: rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital 4.Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses) 5.Patients with known bleeding diathesis or coagulation disorder 6.History of previous intracranial bleed at any time, gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days 7.Ischemic stroke within the previous 14 days 8.Patients considered to be at risk of bradycardic events ([eg, known sick sinus syndrome or second or third degree atrioventricular (AV) block]) unless already treated with a permanent pacemaker 9.Coronary-artery bypass grafting in the past 5 years 10.Known severe liver disease (eg, ascites or signs of coagulopathy) 11.Renal failure requiring dialysis or anticipated need for dialysis during the course of the study 12.Pregnancy or lactation 13.Life expectancy < 1 year 14.Any condition which in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer) 15.Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse) 16.Participation in previous study with ticagrelor if treated with ticagrelor. Previous randomization in the present study 17.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 18.Participation in another clinical study with an investigational product during the preceding 30 days
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