EUCTR2008-002332-15-SE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled study to evaluate the transthoracic Doppler echocardiography method as a non-invasive method for coronary function measurements; ability to detect short-term statin effects in patients with increased cardiovascular risk
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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
- •1. Males aged 45-75 years or females aged 60-75 years inclusive
- •2. Carotid and/or femoral atherosclerotic plaque(s), defined as a distinct area with an
- •intima media thickness (IMT) >50% thicker than that of neighbouring sites
- •(visually judged), as previously assessed by carotid ultrasound examination within
- •the last 5 years
- •3. Dyslipidaemia: Apolipoprotein (Apo)B/A1 ratio >0.60
- •4. Provision of signed informed consent
- •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
- •1. Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid,
- •cholesterol absorption inhibitor, within the last 6 months before randomisation
- •2. Treatment with Persantin® or Asasantin® or other dypyridamole-like drugs
- •3. Treatment with glitazones or other peroxisome proliferator-activated receptors
- •(PPAR) a/? agonists, metformin or insulin within the last 6 months
- •4. Known hypersensitivity to statins, adenosine or mannitol
- •5. Haemoglobin A1c (HbA1c) >7.5 % (Swedish standard) or random glucose
- •>15 mmol/L at Enrolment visit
- •6. Initiation, cessation or dose change in any anti-diabetic medication within the last
- •3 months before randomisation
- •7. Initiation, cessation or dose change in any treatment with beta-blockers,
- •Angiotensin-Converting Enzyme inhibitors (ACEi) or Angiotensin receptor
- •blockers (ARBs) within the last 3 months before randomisation
- •8. Uncontrolled hypertension according to the investigator
- •9. Current smoking or snuff tobacco use
- •10. Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack
- •(TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last
- •6 months before randomisation
- •11. Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus
- •node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic
- •obstructive pulmonary disease (COPD) or asthma
- •12. History of myopathy, alcohol or drug abuse, epilepsy or seizures
- •13. A calculated creatinine-clearance corresponding to a GFR <60 ml/min (Cockroft-Gault), Creatine kinase (CK) > 3 x upper limit of normal (ULN),
- •liver transaminases > 1.5 x ULN or anaemia
- •14. Hypothyroidism, in terms of a thyroid stimulating hormone (TSH) = 1.5 x ULN
- •(patients with diagnosed hypothyroidism on replacement therapy are allowed
- •provided they do not meet this TSH criterion)
- •15. Asian ethnicity, treatment with Vitamin K antagonists, protease inhibitors, rifampicine, cyclosporine or high-dose treatment with macrolide antibiotics
- •16. Malignant disease (except in patients who have been disease-free >5 years or whose only malignancy has been basal or squamous cell skin carcinoma), kidney disease, hepatic disease or inflammatory bowel disease
- •17. Systemic inflammatory disease or use of systemic corticosteroid treatment
- •18. Positive screen for Serum Hepatitis B Surface Antigen, Hepatitis C Antibodies and
- •human immunodeficiency virus (HIV)
- •19. Donation of blood or plasma in any amount during the month prior to baseline visit or in excess of 170 mL during the 3 months prior to study start.
- •20. Previous bone marrow transplant (excludes only participation in the genetic
- •21. Whole blood transfusion within 120 days of the date of genetic sample collection
- •22. Intake of any investigational product within the last month before enrolment
- •23. Any other condition prohibiting study participation at the discretion of the
- •investigator
研究者
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