EUCTR2019-002578-29-NL进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- ACS with PCI of Infarct Related Artery (IRA)
- •- Multi Vessel Disease (MVD)
- •- FFR of non-IRA lesion 0.67 - 0.80
- •Subjects must have an eligible LDL-C level via local lab assessment based on statin use at screening:
- •- No statin use: = 130 mg/dL (3.3 mmol/l)
- •- Non-intensive statin use (see Table): = 80 mg/dL (2.0 mmol/l)
- •- Intensive statin use (see Table): = 60 mg/dL (1.6 mmol/l)
- •- Age = 18 years at screening
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Refusal or inability to provide informed consent
- •- Prior coronary artery bypass graft
- •- Known left ventricular ejection fraction (LVEF) < 30%
- •- Left main stem stenosis >50%
- •- Contra-indication for dual antiplatelet therapy
- •- Chronic total occlusion of a non-IRA
- •- 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.
- •- Known severe kidney disease defined as an eGFR < 30 ml/min.
- •- 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 urine or 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.
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