Switching from clopidogrel to prasugrel to protect early invasive treatment in acute coronary syndromes

• Conditions: Patients with acute coronary syndromes without persistent ST-segment elevation; MedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005114-11-IT
• Lead Sponsor: AZIENDA USL DI FORLI'

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-22
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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