acute coronary syndrome without ST segment elevation MedDRA version: 9.1 Level: HLGT Classification code 10011082 Term: Coronary artery disorders
Conditions
Interventions
Trade Name: TORVAST
Pharmaceutical Form: Tablet
INN or Proposed INN: Atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical Form: Tablet
I
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will study consecutive patients admitted to the Coronary Care Unit and the Cardiology Word of the Catholic University Hospital (Policlinico ?Gemelli?) in Rome with a diagnosis of Non-ST elevation ACS (NST-ACS). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: inflammatory and autoimmune diseases, active infections, neoplasms, use of anti-inflammatory or immunosuppressive drugs, age > 75 years, EF < 45% on admission, heart failure, conditions that contraindicate the use of statins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the possible effects of statin therapy on the number and function of the particular subsets of T lymphocytes, CD4+CD28null T cells and Treg, in patients with ACS and to establish whether or not these effects are clinically relevant.;Secondary Objective: nd;Primary end point(s): Primary end-point will be the reduction in number and function of CD4+CD28null T cells and Treg. This end-point will be evaluated both in vivo and ex-vivo. | — |
Countries
Italy
Outcome results
None listed