Condition category
Circulatory System
Date applied
13/01/2006
Date assigned
20/01/2006
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ascan Warnholtz

ORCID ID

Contact details

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

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

http://www.klinik.uni-mainz.de/2-Med

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

  1. 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.

Additional files

Editorial Notes