Patients with acute coronary syndromes without persistent ST-segment elevation MedDRA version: 14.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: EFIENT*28CPR RIV 10MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PRASUGREL HYDROCHLORIDE
CAS Number: 389574-19-0
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
AZIENDA USL DI FORLI'
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 year old with typical chest pain lasting >30 min and at least one of the following features: ST-segment shift >1 mV in 2 adjacent ECG leads and/or the presence of negative T-waves (?3 mm depth) or the isolated elevation of cardiac troponin T. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Any prior thienopyridine treatment, planned “upstream treatment” with IIB/IIIA intravenous receptor blockers (GPI), need for chronic oral anticoagulation, recent fibrinolytic administration, increased bleeding risk or anaemia. We will also exclude patients with body weight 60 kg and/or ?75 yrs old patients ( to exclude patients indicated for 5 mg MD which would introduce further noise into pharmacodynamic comparison due to the small numbers of observations) and patients with a previous history of TIA/stroke (contraindicated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to assess the level of platelet inhibition associated with switching a group of intermediate-to-high NSTEACS patients from the standard clopidogrel treatment (up to LD 600/75 mg MD) to 3 different switching strategies using different prasugrel dosage.;Secondary Objective: Evaluation of clinical safety in terms of death, reinfarction and major bleeding.;Primary end point(s): The difference of residual platelet reactivity index (VASP) at 4 hours after randomization as compared with the level showed at the time of blood sample taken immediately before diagnostic catheterization (baseline 2 sample), between the group of patients switched to prasugrel LD of 60 mg /MD 10 mg and the group of patients kept on clopidogrel MD.;Timepoint(s) of evaluation of this end point: 4 hours after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Comparison of different prasugrel dosages among themselves and with clopidogrel in terms of PRI 2) Comparison of different prasugrel dosages among themselves and with clopidogrel in terms of PRU 3) Comparison of different prasugrel dosages among themselves and with clopidogrel in terms of PFA-100 parameters (time closure);Timepoint(s) of evaluation of this end point: Same timepoint as for the primary end point | — |
Countries
Italy
Contacts
Public ContactU.O. Cardiologia
Azienda USL Forli'
Outcome results
None listed