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临床试验/EUCTR2009-013228-21-GB
EUCTR2009-013228-21-GB进行中(未招募)不适用

Prevention of atrial oxidative stress and electrical remodelling in patients undergoing cardiac surgery: randomised placebo-controlled trial of perioperative high-dose atorvastatin - Do statins prevent atrial rhythm disturbances after cardiac surgery?

niversity of Oxford0 个研究点开始时间: 2010年6月18日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

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

  • Patients who are:
  • 1. Willing and able to give informed consent for participation in the study
  • 2. In normal sinus rhythm at the time of surgery
  • 3. Stable and requiring elective cardiac surgery.
  • 4. Able (in the Investigators’ opinion) and willing to comply with all study requirements.
  • 5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • ?Age>80yrs
  • ? Female participant who is pregnant, lactating or planning pregnancy during the
  • course of the study.
  • ? Women of child-bearing potential without appropriate contraceptive measures. These
  • include oral contraceptive pills, Intrauterine contraceptive devices etc
  • ? History of obstructive hepatobiliary disease or other serious hepatic disease or preoperative ALT >2-fold the upper limit of normal or alcohol abuse
  • ? Creatinine >200 umol/L
  • ? Untreated hypothyroidism
  • ? Family history of hereditary muscle disorders
  • ? Known intolerance to statins or history of muscle toxicity with fibrates or statins.
  • ? Ongoing use of fibrates, niacin or of agents that are strong inhibitors of cytochrome
  • P-450 or the P-glycoprotein within a month preceding randomization (cyclosporine,
  • azole antifungals, such as itraconazole and ketoconazole, macrolide antibiotics, such
  • as erythromycin and clarithromycin, protease inhibitors, nefazodone, verapamil,
  • amiodarone or large quantity of grapefruit juice (= 1L/day) Patients on treatment with anti arrhythmic agents, other than beta-adrenergic receptor blockers.
  • ? Participant who is terminally ill or is inappropriate for placebo medication.

研究者

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