Effect of coadministration of ezetimibe with statin therapy versus statin therapy alone on flow mediated vasodilation in patients with coronary artery disease
| ISRCTN | ISRCTN34110682 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34110682 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/09/2008
- Registration date
- 17/09/2008
- Last edited
- 17/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ascan Warnholtz
Scientific
Scientific
Johannes Gutenberg-Universität Mainz
Department of Medicine II
Langenbeckstrasse 1
Mainz
D-55131
Germany
Study information
| Study design | Phase IV, double-blind, two-arm, parallel-group, randomised controlled trial (single-centre) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CEZAR |
| Study objectives | Atorvastatin 80 mg per day is more effective in the improvement of flow-mediated dilation of the right brachial artery than atorvastatin 10 mg plus ezetimibe 10 mg per day despite comparable reduction of plasma low-density lipoprotein (LDL) cholesterol concentration. |
| Ethics approval(s) | 1. Ethics Committee of the Medical Association of Hamburg (Ethik-Kommission der Ärztekammer Hamburg), approved on 13/03/2003 2. State Medical Board of Registration in Rhineland-Palatinate (Landesärztekammer Rhineland-Palatinate), approved on 07/11/2005 |
| Health condition(s) or problem(s) studied | Stable coronary artery disease |
| Intervention | Arm 1: Atorvastatin (oral) 80 mg per day for 8 weeks Arm 2: Atorvastatin (oral) 10 mg + ezetimibe (oral) 10 mg per day for 8 weeks Ultrasonic measurements of endothelial function were carried out at the beginning of treatment and at the end of the 8-week pharmacological intervention. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ezetimibe and atorvastatin |
| Primary outcome measure | Effect of treatment on the absolute change (in percentage) in flow-mediated dilation (FMD) at 8 weeks compared to baseline. |
| Secondary outcome measures | Effect of treatment, at 8 weeks compared to baseline, on the following: 1. Absolute change (in percentage) in nitroglycerin-mediated dilation (NMD) 2. Absolute change in LDL cholesterol plasma concentration 3. Absolute change in C-reactive protein plasma concentration 4. Absolute change in uric acid plasma concentration 5. Absolute change in 8-iso-prostaglandin F2 alpha urine concentration |
| Overall study start date | 01/07/2003 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 58 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Johannes Gutenberg-Universität Mainz
Mainz
D-55131
Germany
D-55131
Germany
Sponsor information
Johannes Gutenberg-University Mainz (Germany)
University/education
University/education
c/o Prof. Dr. T. Münzel
Department of Medicine II
Langenbeckstrasse 1
Mainz
D-55101
Germany
| Website | http://www.uni-mainz.de/eng |
|---|---|
"ROR" |
https://ror.org/023b0x485 |
Funders
Funder type
University/education
University of Hamburg (Germany)
No information available
Johannes Gutenberg-University Mainz (Germany)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Johannes Gutenberg University of Mainz, University of Mainz, Johannes Gutenberg University Mainz, JGU
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
