Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Acute Coronary Syndrome (EVANACS)

This study has been completed.
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00855257
First received: March 2, 2009
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

The investigators' work proposes to evaluate the effectiveness of the Acid Nicotinique (Niaspan®), only molecule currently marketed, ready to raise the plasmatic levels of HDL-c. This effectiveness will be tested among patients having presented recently an acute coronary syndrome. The effectiveness of the molecule will be appreciated versus placebo after randomization.

The technique of evaluation of this effectiveness will be the analysis of the vasodilatation endothelial-dependent measured on the level huméral (by echography high resolution).

The awaited result is an improvement of 2% in value absolute of this vasodilatation between the initial test and the end of study for the patients receiving the acid nicotinic versus those receiving the placebo (3 months of treatment after inclusion). The calculation of the sample necessary to achieve this goal envisages 70 patients led at the end of the study, divided into two groups of treatment (acid nicotinic or Placebo).

Such a result if it were obtained would be higher than that found in studies evaluating the effect on the vasomotricity endothelial statins or inhibitors of the enzyme of conversion.


Condition Intervention Phase
Acute Coronary Syndrome (ACS)
Drug: Acid Nicotinique
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Patients Presenting a Recent Acute Coronary Syndrome.

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Measure of endothelial function by high resolution echography in response to nitric agent [ Time Frame: Within the first 7 days of ACS and 3 months by treatment with nicotinic acid ]

Secondary Outcome Measures:
  • Measure of plasmatic CRP, cytokines, lipid level [ Time Frame: Within the first 7 days of ACS and 3 months by treatment with nicotinic acid ]

Enrollment: 93
Study Start Date: June 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
treatment by acid nicotinique
Drug: Acid Nicotinique
Placebo Comparator: 2
Treatment by placebo
Drug: Placebo

Detailed Description:

The pharmacological assumption of responsibility of the coronary disease has rested partially for a few years on the regulation of the inhibitors of the HMG CoA reductase (statins). These drugs initially address to the quantitative anomalies Lipoproteins of low density (LDL cholesterol). The objectives laid down by the national recommendations (obtaining a plasmatic rate < 1gr/l in coronary secondary prevention or among patients at the high vascular risk) or international, implies their broad regulation with the waning of the coronary syndromes. It can exist in addition among many patients of the qualitative or quantitative anomalies of the Lipoproteins of High density (HDL-c) whose correlation to the coronary risk was beforehand largely shown. The anomalies of HDL-c are not very sensitive to the hygieno-dietetic rules.

To intervene on the plasmatic levels of the lipoproteins is thus essential with the improvement of the forecast of the proven coronary patients.

The investigators know since the beginning of the years 1980 (work of Furchgott and Moncada) that the endothelium is a powerful integrator of the vascular risk, in particular in its aspect of regulation vasomotrice.

Methods of investigation of the endothelium were developed on the coronary floor or the level of the peripheral arteries to analyze the vasomotricity endothelial dependent. Among these methods the study of the vasomotricity on the level huméral is validated, largely used and correlated in many tests with the forecast of the patients presenting a high vascular risk.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent written of the patient
  • Acute coronary syndrome going back to less than 7 days by the rise higher than 0.10 in troponin associated at least one in the following elements:(symptoms of myocardiac ischaemia, appearance of pathological waves Q, disturb repolarisation in connection with an ischaemia (known or under shift of the segment ST).
  • HDL - C lower than 0.4 g/l
  • FMD < 7%

Exclusion Criteria:

  • Antecedents of myopathy induced by a statin or severe reaction of over-sensitiveness to an inhibitor of the HMG CoA réductase (statins).
  • Antecedent of family hypercholesterolemia of homozygote type.
  • Women pregnant, nursing, likely to be pregnant and not using chemical or mechanical contraception or presenting a positive test of pregnancy blood (b-HCG).
  • Subjects whose substitute hormonal treatment or oral contraception was initiated in the 3 previous months Visit 0.
  • Active hepatic pathology or hepatocellular insufficiency (doubly of the gammas WP; TGP > 3 times the normal)
  • Renal insufficiency engraves with clearance of creatinin < 30 ml/min.
  • LDL<0.70gr/l, triglycerides ³ 400 Mg dL (4.52 mmol/L), hbA1c > 8.5%, HDL cholesterol > 0 40g/l.
  • Evolutionary cancer
  • Use of the following concomitant treatments: insulin, nitrated derivatives
  • Antecedents of alcoholism and/or catch dopes during the last year.
  • CPK ³ 3 times higher limit of the normal and fraction MB of CPK < 2 times limit higher of the normal than visit 1. If the CK-MB are not available, one will take into account a value of CPK > 3 times the limit higher of the normal and cardiac Troponin (I or T) < 0.10 g/l than visit 1.
  • Clinical history of permanent systolic hypotension (NOT < 90 mmHg) or permanent not controlled hypertension (NOT > 200 mmHg gold PAD > 110 mmHg).
  • Coronary bridging in the 3 months before inclusion (V1).
  • Occurred of fibrillation ventricular, tachycardia ventricular constant (other which RIVETTED), complete and permanent auriculo-ventricular Bloc, which has occurred of auricular fibrillation with a ventricular rate/rhythm not controlled (> 130 bpm), or ventricular rate/rhythm in the 4 weeks preceding visit 1.
  • Cerebral vascular accident, severe infection, péricardite acute or any other obviousness of known systemic embolism not controlled
  • Hypothyroïdie defined by a rate of TSH > 1,5 times higher limit of the normal
  • Serious or unstable conditions psychological or medical which according to the opinion of the investigator, would compromise the safety of the patient or his participation in the study.
  • Participation in another clinical trial (other than registers not raising of a biomedical law of research) with treatment the study or having received a treatment the study in the 4 weeks preceding inclusion in the study.
  • Patients under supervision or trusteeship or without Social Security cover or impossibility of following the specific procedures of the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00855257

Locations
France
Hôpital de Rangueil
Toulouse, France, 31000
Sponsors and Collaborators
French Cardiology Society
Merck Serono International SA
Investigators
Principal Investigator: meyer elbaz, md phd hopital de rangueil service of cardiology
  More Information

No publications provided

Responsible Party: Pr Meyer Elbaz, Rangueil Hospital
ClinicalTrials.gov Identifier: NCT00855257     History of Changes
Other Study ID Numbers: 2005-07
Study First Received: March 2, 2009
Last Updated: July 8, 2009
Health Authority: France: Ministry of Health

Keywords provided by French Cardiology Society:
Acid nicotinique
FLOW MEDIATED DILATATION (FMD)
HDL-C< 0.4 G/L

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Nicotinic Acids
Niacin
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 22, 2014