Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in 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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Acute Coronary Syndrome (ACS)
Acid Nicotinique, Placebo
Hôpital de Rangueil
French Cardiology Society
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00855257
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.
Acute Coronary Syndrome
An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.
Coronary Vessel Anomalies
Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.
Coronary-subclavian Steal Syndrome
A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.
Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.
The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a rec...
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in su...
This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the de...
The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).
The objective of this study is to investigate whether intravenous administration (injected into a vein) of acetylsalicylic acid (Aspirin) in doses of 250 and 500 mg is superior to oral tre...
Background Acute coronary syndromes arise from coronary atherosclerosis with superimposed thrombosis. Since factor Xa plays a central role in thrombosis, the inhibition of factor Xa with low-dose ri...
Apical ballooning syndrome (ABS) is uniquely characterized by the acute onset of transient extensive kinesis of the apical and mid portions of the left ventricle without significant epicardial coronar...
We sought to determine the prognosis of patients with acute coronary syndrome without culprit lesion and proof of coronary spasm during 3 years of follow-up.
Sweet's syndrome is characterized by skin lesions and fever. One of the rare extracutaneous manifestations of Sweet's syndrome is cardiovascular involvement including coronary artery occlusion. In thi...
Information about acute coronary syndrome caused by Kawasaki disease-related coronary artery lesions in adults is sketchy. We reviewed the clinical features of 50 adult patients who had an acute coron...