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

Johannes Gutenberg-University Mainz
Department of Medicine II
Langenbeckstr 1
Mainz
55131
Germany

Study information

Study designProspective placebo-controlled double-blind randomized parallel-group single-center two-armed clinical phase IV trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymINEF
Study objectivesTwelve 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) studiedCoronary artery disease (CAD) and known dyslipidemia
InterventionTwelve weeks oral Niacin therapy
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Niacin
Primary outcome measureEffect 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 measuresEffects 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 date19/01/2006
Completion date19/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target number of participants100 subjects, i.e. 50 subjects per treatment group
Key inclusion criteria1. 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 criteria1. 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 enrolment19/01/2006
Date of final enrolment19/05/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Johannes Gutenberg-University Mainz
Mainz
55131
Germany

Sponsor information

Funders

Funder type

Industry

Merck Pharma GmbH

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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