EUCTR2016-005206-19-GB进行中（未招募）1 期
Randomised Controlled Trial with Pravastatin versus Placebo for Prevention of Preeclampsia - STATI
Fundación para la Formación e Investigación Sanitaria (FFIS)0 个研究点目标入组 1,120 人开始时间: 2017年5月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,120
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
入选标准
- •For the screening study:
- •Singleton pregnancy;
- •Live fetus at 35+0-36+6 weeks’ gestation;
- •Informed and written consent.
- •For the randomised trial:
- •Same as for screening
- •High-risk for term-PE at screening by the algorithm combining maternal history and characteristics, MAP, PLGF and sFLT-1;
- •Informed and written consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •For the screening study:
- •Age <18 years;
- •Multiple pregnancy;
- •Unconscious or very ill;
- •Serious mental illness;
- •Learning difficulties;
- •Not fluent in local language and absence of interpreter.
- •For the randomised trial:
- •Same as for screening, but in addition:
- •Major fetal abnormality;
- •Women with established PE;
- •Statin use within 28 days prior to randomisation;
- •Women with contraindications for statin therapy:
- •-Hypersensitivity to pravastatin or any component of the product;
- •-Lactose intolerance
- •-Current or previous cancer
- •-Previous solid organ transplant
- •-Active liver disease (acute hepatitis, chronic active hepatitis) in the past 6 months
- •-Chronic renal disease/insufficiency with baseline serum creatinine >1.5mg/dL
- •-History of myopathy or rhabdomyolysis;
- •-ALT and/or AST levels = 2 x the upper limit of normal
- •-Creatine kinase levels = 5 x the upper limit of normal
- •-Concurrent and chronic (>6 months) use of medications with potential drug interactions with statins, such as immunosuppressive drugs, fibrates, gemfibrozil, niacin, protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitor), erythromycin, clarithromycin, itraconazole, cholestyramine, digoxin, rifampicin (patients will not be excluded if the drug has been discontinued, or is prescribed for a short duration of time);
- •Participating in another intervention study that influences the outcomes of this study.
研究者
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