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临床试验/EUCTR2008-002169-30-GB
EUCTR2008-002169-30-GB进行中(未招募)1 期

A randomised placebo-controlled trial of metformin on progression of carotid atherosclerosis in non-diabetic patients with cardiovascular disease treated with conventional risk reducing agents - CAMERA: Carotid Atherosclerosis: MEtformin for insulin ResistAnce study

Greater Glasgow Health Board, Research and Development Department0 个研究点目标入组 220 人开始时间: 2008年10月9日最近更新:
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
220

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

  • oProven coronary heart disease (prior acute coronary syndrome, prior coronary artery bypass graft or angiographically proven coronary heart disease)
  • oAged 35-75 years
  • oElevated waist circumference as per the International Diabetes Foundation criteria (94cm in men and 80cm in women)
  • oAttending Cardiology outpatient clinics at Glasgow Royal Infirmary, the Western Infirmary, Stobhill Hospital and Royal Alexandra Hospital ; and patients identified at volunteering GP surgeries in Glasgow as approved by the Scottish Primary Care Research Network
  • oAll patients will be on statin medication.
  • 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

  • oPregnancy and/or lactation at screening
  • oPremenopausal woman not on adequate contraception (defined as daily oral hormonal contraception or regular injectable hormonal contraception)
  • oKnown or newly diagnosed diabetes mellitus on oral glucose tolerance testing (OGTT will be performed on subjects with HbA1C 6.0-6.9% and fasting plasma glucose <7.0mmol/L at screening)
  • oScreening results: HbA1C =7.0% and/or fasting plasma glucose =7.0mmol/L
  • oPatients with acute coronary syndrome within the last 3 months
  • oStage 3 or 4 heart failure defined according to the New York Heart Association criteria
  • oUncontrolled angina
  • oContraindications to metformin (example hepatic impairment, renal impairment [eGFR <45 mL/min/1.73m2 at screening], known hypersensitivity to metformin, acute illness [dehydration, severe infection, shock, acute cardiac failure]), and suspected tissue hypoxia will be excluded.

研究者

发起方
Greater Glasgow Health Board, Research and Development Department

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A randomised placebo-controlled trial of metformin... | 临床试验