Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT00855257
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00855257
Study Brief:
Protocol Section:
NCT00855257