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 - PEGASUS - TIMI 54

Astra Zeneca0 个研究点目标入组 700 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Men and women >50 years of age.
•- Person who had a heart attack within 1-3 years ago and at least one additional risk factor:
•* Age *65 years
•* Diabetes mellitus requiring medication
•*Documented history of a second prior presumed spontaneous MI (>1 year ago)
•*Documented history of angiographic evidence of multivessel coronary artery disease (CAD)
•*Chronic, non-end stage renal dysfunction
•- Treated with ASA,
•- Females of child-bearing potential must have a negative urine pregnancy test at enrollment and
•must be willing to use a medically accepted method of contraception that is considered
•reliable in the judgment of the investigator.
•- Written informed consent prior to any study specific procedures.

•- Planned use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel),
•dipyridamole, or cilostazol
•- Planned coronary, cerebrovascular, or peripheral arterial revascularization
•- Concomitant therapy with strong cytochrome P450 3A
•(CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong
•CYP3A inducers.
•- Need for chronic oral anticoagulant therapy or chronic low-molecular-weight
•- Patients with known bleeding diathesis or coagulation disorder
•- Patients with:
•*A history of previous intracranial bleed at any time
•*A central nervous system tumour or intracranial vascular abnormality at any time
•*Intracranial or spinal cord surgery within 5 years, or
•*Gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days
•- History of ischemic stroke at any time
•- Patients considered to be at risk of bradycardic events
•- Coronary-artery bypass grafting in the past 5 years, unless the patient has experienced a spontaneous MI subsequent to the bypass surgery
•- Known severe liver disease
•- Renal failure requiring dialysis
•- Pregnancy or lactation
•- Life expectancy < 1 year
•- Participation in previous study with ticagrelor if treated with ticagrelor.

发起方

Astra Zeneca