Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
INEF
Study information
Scientific title
Acronym
INEF
Study hypothesis
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
Ethics-commission of the country physicians chamber Rhineland-Palatinate (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz)
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
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Coronary artery disease (CAD) and known dyslipidemia
Intervention
Twelve weeks oral Niacin therapy
Intervention type
Drug
Phase
Phase IV
Drug names
Niacin
Primary outcome measures
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 trial start date
19/01/2006
Overall trial end date
19/05/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 subjects, i.e. 50 subjects per treatment group
Participant 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
Recruitment start date
19/01/2006
Recruitment end date
19/05/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Johannes Gutenberg-University Mainz
Mainz
55131
Germany
Sponsor information
Organisation
Johannes Gutenberg-University Mainz (Germany)
Sponsor details
Langenbeckstr 1
Mainz
55131
Germany
+49 (0)6131/17-7250
muenzel@2-med.klinik.uni-mainz.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Merck Pharma GmbH
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/18822413
Publication citations
-
Results
Warnholtz A, Wild P, Ostad MA, Elsner V, Stieber F, Schinzel R, Walter U, Peetz D, Lackner K, Blankenberg S, Munzel T, Effects of oral niacin on endothelial dysfunction in patients with coronary artery disease: results of the randomized, double-blind, placebo-controlled INEF study., Atherosclerosis, 2009, 204, 1, 216-221, doi: 10.1016/j.atherosclerosis.2008.08.003.