Impact of 12 weeks oral niacin on endothelial function, lipid composition and cardiovascular biomarkers in patients with coronary artery disease: a prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV
| ISRCTN | ISRCTN48365122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48365122 |
| Secondary identifying numbers | INEF |
- Submission date
- 13/01/2006
- Registration date
- 20/01/2006
- Last edited
- 24/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ascan Warnholtz
Scientific
Scientific
Johannes Gutenberg-University Mainz
Department of Medicine II
Langenbeckstr 1
Mainz
55131
Germany
Study information
| Study design | Prospective placebo-controlled double-blind randomized parallel-group single-center two-armed clinical phase IV trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | INEF |
| Study objectives | Twelve weeks oral niacin therapy in addition to standard long-term coronary artery disease (CAD) medication improves flow dependent vasodilation (FMD) in patients suffering from CAD. |
| Ethics approval(s) | Ethics-commission of the country physicians chamber Rhineland-Palatinate (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz) |
| Health condition(s) or problem(s) studied | Coronary artery disease (CAD) and known dyslipidemia |
| Intervention | Twelve weeks oral Niacin therapy |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Niacin |
| Primary outcome measure | Effect of 12 weeks oral niacin therapy in addition to standard long-term CAD medication on flow dependent vasodilation (FMD) in patients suffering from CAD |
| Secondary outcome measures | Effects of niacin therapy on plasma lipid composition, HDL-C levels, LDL, triglycerides, total cholesterol, cholesterol ratio, high sensitivity C-reactive protein (hs-CRP), cardiovascular biomarkers, endothelium-independent nitrogylcerin-induced vasodilation (NMD) and FMD levels. |
| Overall study start date | 19/01/2006 |
| Completion date | 19/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 subjects, i.e. 50 subjects per treatment group |
| Key inclusion criteria | 1. Men or women > 35 and < 80 years of age 2. Documented clinically stable CAD and known dyslipidemia, defined by a low-density lipoprotein cholesterol (LDL >70 mg/dl) and a high density lipoprotein cholesterol (HDL <65mg/dl) 3. A flow-mediated vasodilatation (FMD) of less than 8% 4. Ability of subject to understand character and individual consequences of clinical trial 5. Written informed consent must be available before enrolment in the trial 6. For women with childbearing potential, adequate contraception |
| Key exclusion criteria | 1. Clinical signs of congestive heart failure or left ventricular ejection fraction <30% 2. Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <90 mmHg) 3. Initiation of any of the following medications within the last twelve weeks: aspirin, lipid-lowering agents, calcium antagonists, betablockers, angiotensin converting enzymes inhibitors (ACEI) or angiotensin 1 (AT1) receptor blockers, hormone replacement therapy 4. Use of steroids or chemotherapy drugs within the past year or chronic use of non-steroidal anti-inflammatory drugs except for aspirin 5. Hemodynamically significant valvular heart diseases or hypertrophic obstructive cardiomyopathy 6. Renal dysfunction (creatinine > 2.5 mg/dl) 7. Known hepatic disease or elevation of serum transaminases or gamma glutamyl transferase (gGT) > 2x ULN (upper limit of normal range) 8. Uric acid >10.0 mg/dl 9. Alcohol abuse 10. White blood cell (WBC) count >12,000 or platelet count >500,000 /ul or <75,000 /ul 11. Existence of acute gastric ulcers 12. Existence of acute arterial bleeding 13. Other significant laboratory abnormalities |
| Date of first enrolment | 19/01/2006 |
| Date of final enrolment | 19/05/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Johannes Gutenberg-University Mainz
Mainz
55131
Germany
55131
Germany
Sponsor information
Johannes Gutenberg-University Mainz (Germany)
University/education
University/education
Langenbeckstr 1
Mainz
55131
Germany
| Phone | +49 (0)6131/17-7250 |
|---|---|
| muenzel@2-med.klinik.uni-mainz.de | |
| Website | http://www.klinik.uni-mainz.de/2-Med |
"ROR" |
https://ror.org/023b0x485 |
Funders
Funder type
Industry
Merck Pharma GmbH
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No |
