Effect of coadministration of ezetimibe with statin therapy versus statin therapy alone on flow mediated vasodilation in patients with coronary artery disease

Completed

• Conditions: Stable coronary artery disease; Circulatory System; Chronic ischaemic heart disease

• Registration Number: ISRCTN34110682
• Lead Sponsor: Johannes Gutenberg-University Mainz (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Both males and females, over 18 years old
2. Angiographic, documented coronary heart disease with:
a. Generalized wall irregularities (stenosis <40%) and/or
b. Existence of at least one stenosis >50%
3. Endothelial dysfunction with flow-dependent dilation of the brachial artery of <6%
4. LDL cholesterol >100 mg/dl
5. Written consent of the patients for participation in the study

Exclusion Criteria

1. Acute coronary syndrome
2. Stroke or peripheral revascularisation within 12 weeks before study enrolment
3. Known intolerance towards HMG CoA reductase inhibitors or ezetimibe
4. Clinically significant valvular disease
5. Hypertrophic obstructive cardiomyopathy
6. Sustained ventricular arrhythmias
7. Syncope within four weeks before the study
8. Severe respiratory disease
9. Unstable diabetes mellitus requiring frequent adjustments in insulin doses
10. Known hypothyroidism
11. Known hyperthyroidism
12. Gastrointestinal disorders (such as Crohn's disease), which could lead to decreased absorption of the study drug
13. Chronic liver disease
14. History of pancreatitis
15. History of organ transplantation
16. Clinically significant heart failure with left ventricular ejection fraction of <30%
17. Symptoms of orthostatic hypotension, or a systolic blood pressure in the supine position of <90 mmHg
18. Systolic blood pressure >180 mmHg and/or diastolic blood pressure >105 mmHg despite antihypertensive therapy
19. Elevated serum creatinine of >2.0 mg/dL or known nephrotic syndrome
20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times above the upper normal limit
21. Triglyceride level >400 mg/dl
22. Treatment with an HMG CoA reductase inhibitor during the last three months
23. Treatment with ezetimibe during the last three months
24. Initiation of treatment with an angiotensin converting enzyme (ACE) inhibitor, AT1-receptor antagonist, or calcium channel blocker within the past four weeks
25. Treatment with fibrates or colestipol during the last three months
26. Current treatment with macrolide antibiotics, niacin or antimycotics of azole type
27. Expected problems with compliance or follow-up visits (no fixed residence, alcohol or drug abuse, history of failure of medical advice, psychiatric diseases, etc.)
28. For women: pregnancy, breast feeding or possible pregnancy (women of childbearing age on an acceptable method of contraception may be included)
29. Simultaneous participation in another study
30. Therapy with another investigational product within a period of 30 days before the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified