EUCTR2015-005130-22-BE进行中（未招募）1 期
Randomised Controlled Trial with Pravastatin versus Placebo for Prevention of Pre-eclampsia - STATI
Fundación para la Formación e Investigación Sanitaria (FFIS)0 个研究点目标入组 2,000 人开始时间: 2016年9月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
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
- Female
入选标准
- •- ? Age > 18 years;
- •- ? Singleton pregnancies;
- •- ? Live fetus at 11-13 weeks of gestation;
- •- ? High-risk for preterm-PE at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (placental growth factor);
- •?- Be fluent in the local language (otherwise interpreters will be used)
- •- ? 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 2000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •-? Statin use in current pregnancy (administration must have ceased >28 days prior to randomisation);
- •-? Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks’ assessment;
- •-? Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness;
- •-? Women with contraindications for statin therapy:
- •a.? Hypersensitivity to Pravastatin or any component of the product;
- •b. Active liver disease in the past 6 months (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes (= 2 x the upper limit of normal values for serum transaminases [ALT and/or AST], confirmed either by available blood results within the recruiting hospital within the last 6 months or blood taken prior to randomisation));
- •c.? History of myopathy or rhabdomyolysis;
- •- ? Creatine kinase = 5 x the upper limit of normal
- •-? Women with any of the following conditions:
- •a. ? Status post solid organ transplant;
- •b.? Chronic renal disease/insufficiency with baseline serum creatinine >1.5mg/dL;
- •c.? Cancer;
- •-? Autoimmune diseases which may induce preeclampsia
- •-? Lactose intolerance
- •-? 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;
- •-? Plans to deliver in a non-network site,
- •-? Any other reason the clinical investigators think will prevent the potential
研究者
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