Status:
COMPLETED
Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Acute Coronary Syndrome
Lead Sponsor:
French Cardiology Society
Collaborating Sponsors:
Merck Serono International SA
Conditions:
Acute Coronary Syndrome (ACS)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 wi...
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 initia...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00855257
Start Date
June 1 2007
End Date
May 1 2009
Last Update
July 10 2009
Active Locations (1)
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1
Hôpital de Rangueil
Toulouse, France, 31000