Patients with acute coronary syndromes without ST-segment elevation (NSTEACS). MedDRA version: 15.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CLOPIDOGREL
CAS Number: 113665-84-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical
Sponsors
A.O. UNIVERSITARIA INTEGRATA DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects (aged 18 to 75 years) with non–ST-segment elevation ACS (NSTEACS) and GRACE risk score=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: -Cardiogenic shock at recruitment; - Refractory ventricular arhythmias;- Prior Transient Ischemic Attack or Stroke; -Active internal bleeding or history of bleeding diathesis;-Increased bleeding risk for:Propensity to bleed (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, active peptic ulcer disease, or severe hepatic impairment); arteriovenous malformation, or aneurysm;concomitant use of medications that increase the risk of bleeding as warfarin and fibrinolytic therapy; chronic use of non-steroidal anti-inflammatory drugs [NSAIDS] different from aspirin; CABG; platelet count o = 33; -Intolerance or allergy to aspirin or clopidogrel;-Severe illness with life expectancy less than 1 year;-Test positive for pregnancy (based on a urine or serum pregnancy test) at presentation;-Women who have given birth within the previous 90 d;-Any condition associated with poor treatment compliance, including alcoholism, mental illness (or -Treatment with psychotropic drugs), or drug dependence.- Women of childbearing age not using contraception;- Women during lactation;- Patients in emergency situations;- Subjects incapable of giving legal consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if surrogate pharmacodynamic tests (platelet function tests) predict the bioavailability of thienopyridine drugs as assesses by measuring plasma levels of clopidogrel and its active metabolite at different time points. To define usefulness and timing of pharmacodynamic assessment for the prediction of clopidogrel bioavailability.;Secondary Objective: To assess whether log (AUC) of the prodrug can explain the index of platelet response measured in time instants different from Ts0; Measurement of pharmacodynamic response as platelet aggregation (AU/min) and PRI (%) at all points of the curve different from Ts0;Determination of the frequency of polymorphic variants of genes CYP2C19, ABCB1 and PON1;Evaluation of the difference in logAUC, PRI and platelet aggregation, in relation to the polymorphic variants of genes CYP2C19, ABCB1 and PON1 at all point of the curve;Measurement of the correlation between maximum intensity of platelet aggregation induced by ADP (AU%/min) and PRI(%);To measure the correlation between intensity of aggregation (AU%/min) at the end of the observation (ts17) , PRI (%) and pharmacokinetic parameters (AUC,logAUC,Cmax,Tmax).;Primary end point(s): PRI (%);Timepoint(s) of evaluation of this end point: calculated at each time point (from TS1 to TS17) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Maximum intensity of platelet aggregation (%AU/min) induced by ADP and AA calculated from TS0 to TS17 for each test;2)Extent of platelet aggregation at Ts17;3)Cmax (ng/ml),Tmax,AUC of the prodrug,of the active and inactive metabolite;4)Frequency of polymorphic variants of CYP2C19,PON1,ABCB1 gene;5)Concentration (ng/ml) of serum TBX2 measured at TS0, TS6 TS9, TS12, TS15;6)Concentration (pg mg-1 creatinine) of urinary 11-dehydro TXB2 measured at Tu0, TU1, TU2, TU3, TU4;Timepoint(s) of evaluation of this end point: 1)From TS0 toTS17 for each test,2)Ts17;3)Cmax (ng/ml),Tmax,AUC of the prodrug,of the active and inactive metabolite;4)Frequency of polymorphic variants of CYP2C19,PON1,ABCB1 gene;5)Ts0, Ts6 Ts9, Ts12, Ts15;6)Tu0, Tu1, Tu2, Tu3, Tu4 | — |
Countries
Italy
Contacts
Public ContactU.O. Medicina Interna C
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed