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

NCT00855257 | Completed Phase 3 DMC

• 1 other identifier: 2005-07
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome (ACS)

Keywords

Acid nicotinique; FLOW MEDIATED DILATATION (FMD); HDL-C< 0.4 G/L

Outcome Measures

Primary Outcomes (1)

• Measure of endothelial function by high resolution echography in response to nitric agent

  Within the first 7 days of ACS and 3 months by treatment with nicotinic acid

Secondary Outcomes (1)

• Measure of plasmatic CRP, cytokines, lipid level

  Within the first 7 days of ACS and 3 months by treatment with nicotinic acid

Study Arms (2)

1

EXPERIMENTAL

treatment by acid nicotinique

Drug: Acid Nicotinique

2

PLACEBO COMPARATOR

Treatment by placebo

Drug: Placebo

Interventions

Acid Nicotinique DRUG

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• Merck Serono International SA: collaborator

Study Sites (1)

Hôpital de Rangueil

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• meyer elbaz, md phd

  hopital de rangueil service of cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 4, 2009
• Study Start: June 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 10, 2009

Record last verified: 2009-07

Locations

FR (1)