NL-OMON52478招募中不适用
Functional Improvement of non-infarcT relaTed coronary artery stenosis by Extensive LDL-C Reduction with a PCSK9 Antibody. - FITTER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
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 99（—）
入选标准
- •- ACS with PCI of infarct related artery
- •- Multivessel Disease (MVD)
- •- FFR of non-IRA lesion: 0.67 - 0.85
- •- Age >= 18 years at screening
排除标准
- •- Refusal or inability to provide informed consent
- •- Prior coronary artery bypass graft
- •- Known left ventricular ejection fraction (LVEF) < 30%
- •- Untreated functional left main stem stenosis (FFR <= 0.80)
- •- Contra-indication for antithrombotic therapy according to ESC guidelines
- •- Non-IRA stenosis not amenable for PCI treatment (operator*s decision)
- •- Complicated IRA treatment, with one or more of the following:
- •- Extravasation
- •- Permanent no re-flow after IRA treatment (TIMI flow 0-1)
- •- Inability to implant a stent
- •- Known severe cardiac valve dysfunction that will require surgery in the
- •follow-up period.
- •- Severe kidney disease defined as an eGFR < 30 ml/min.
- •- Known severe liver disease defined as Child-Pugh score of 10-15.
- •- Female subject is pregnant, breastfeeding or planning to become pregnant or
- •planning to breastfeed during treatment and for an additional 15 weeks after
- •the last dose of investigational product. Females of childbearing potential
- •should only be included in the study after a confirmed menstrual period and a
- •negative highly sensitive serum pregnancy test.
- •- Female subjects of childbearing potential unwilling to use 1 acceptable
- •method of effective contraception during treatment and for an additional 15
- •weeks after the last dose of investigational product.
- •- Female subject who has not used an acceptable method(s) of birth control for
- •at least 1 month prior to screening, unless the female subject is sterilized or
- •postmenopausal.
研究者
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