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

• Conditions: In this study the IMP, rosuvastatin, is used as a tool compound for creating favourable lipid-altering, anti-inflammatory or other pleiotropic effects which are believed to change coronary flow reserve (CFR).

• Registration Number: EUCTR2008-002332-15-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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
sampling)
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified