NL-OMON54553招募中3 期
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome - AEGIS II study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,650
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
- 18 至 64（—）
入选标准
- •Capable of providing written informed consent and willing and able to adhere to
- •all protocol requirements.
- •Male or female at least 18 years of age at the time of providing written
- •informed consent.
- •Evidence of myocardial necrosis in a clinical setting consistent with type I
- •(spontaneous) MI (STEMI or NSTEMI) caused by atherothrombotic coronary artery
- •diseaseas defined by the following:
- •a. Detection of a rise and / or fall in cardiac troponin I or T with at least 1
- •value above the 99th percentile upper reference limit.
- •b. Any 1 or more of the following:
- •i. Symptoms of acute myocardial ischemia (ie, resulting from a primary coronary
- •artery event).
- •ii. New (or presumably new) significant ST/T wave changes or left bundle branch
- •iii. Development of pathological Q waves on electrocardiogram.
- •iv. Imaging evidence of new loss of viable myocardium or regional wall motion
- •abnormality in a
- •pattern consistent with an ischemic etiology.
- •v. Identification of intracoronary thrombus by angiography.
- •Note: Electrocardiograms obtained as part of standard of care can be used to
- •support or confirm the index MI.
- •No suspicion of acute kidney injury at least 12 hours after IV contrast agent
- •administration (subjects who have undergone angiography) or after first medical
- •contact for the index MI (subjects who have not undergone angiography). There
- •must be documented evidence of stable renal function defined as no more than an
- •increase in serum creatinine < 0.3 mg/dL (~27 µmol/L) from pre-contrast serum
- •creatinine value.
- •Evidence of multivessel coronary artery disease defined as meeting 1 or more of
- •the following criteria:
- •c. At least 50% stenosis of the left main coronary artery or at least 2
- •epicardial coronary artery
- •territories (left anterior descending, left circumflex,
- •right coronary artery) on catheterization performed during the index
- •hospitalization.
- •d. Prior cardiac catheterization documenting at least 50% stenosis of the left
- •main coronary artery or at least 2 epicardial coronary artery territories or
- •left anterior descending, left circumflex, right coronary artery.
- •e. Prior percutaneous coronary intervention and evidence of at least 50%
- •stenosis of at least 1 epicardial coronary artery territory different from
- •prior revascularized artery territory .
- •f. Prior multivessel coronary artery bypass grafting.
- •Presence of established cardiovascular risk factor(s), defined as:
- •a. Diabetes mellitus on pharmacotherapy.
- •b.2 or more of the following :
- •g. Age >= 65 years.
- •h. Prior history of MI.
- •Peripheral arterial disease.
排除标准
- •* Ongoing hemodynamic instability
- •* Evidence of hepatobiliary disease
- •* Evidence of severe chronic kidney disease
- •* Plan to undergo scheduled coronary artery bypass graft surgery after
- •randomization, as determined at the time of screening.
- •* Body weight < 50 kg.
- •* Allergy to soy bean or peanuts
- •* Known or suspected hypersensitivity to the investigational product, or to any
- •excipients of the investigational product or placebo (albumin)
- •* A known history of IgA deficiency or antibodies to IgA
- •* Other severe comorbid condition, concurrent medication
- •For a complete list refer to p41, 42 and 43 of the Protocol.
研究者
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