Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): Acid Nicotinique; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acid nicotinique; FLOW MEDIATED DILATATION (FMD); HDL-C< 0.4 G/L