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