Ajuste del tratamiento con tirofibán en pacientes que presentan resistencia a la aspirina o al clopidogrel: 3T/2RTailoring Treatment with Tirofiban in patients showing Resistance to aspirin and/or Resistance to clopidogrel: 3T/2R - 3T/2R

• Conditions: Pacientes con enfermedad coronaria que van a someterse a una intervención coronaria percutánea.Patients with coronary disease undergoing percutaneous coronary intervention; MedDRA version: 9.1Level: LLTClassification code 10011099Term: Coronary disease

• Registration Number: EUCTR2007-002427-32-ES
• Lead Sponsor: IVERSITA' DEGLI STUDI DI FERRARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1.Patients will be enrolled only if there is a reasonable expectation that PCI will be conducted within 2 hours. [Patients should be CK-MB negative (to avoid CK washout with revascularization) and also cTnI/T negative, whereas any other marker of high risk, including TIMI or GRACE high risk score will not lead to patient exclusion
2.All consecutive patients with stable or unstable coronary artery disease showing aspirin and/or clopidogrel resistance (AR) will be enrolled. These include:
Patients with clinical indication to undergo angiography for possible revascularisation.
Patients with AR in whom catheter-based coronary intervention is planned based on previous angiogram.
Patients with AR, presenting with non-ST segment elevation ACS (NSTEACS), independent of TIMI risk score or presence of high-risk features according to ESC guidelines (except for cTnI/T elevation).

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

1.Patients who can not give informed consent or have a life expectancy of <1 year
2.Evolving or Ongoing myocardial infarction (MI) (Persistence of or developing Q wave or ST segment elevation at ECG with or without typical chest pain or typical rapid rise and fall CK-MB or new LBBB)
3.cTnI/T positive or increased beyond upper limit of normal according to local laboratory
4.Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
5.Serum creatinine ?2.5 mg/dl (221 ?mol/L)
6.Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
7.Previous stroke or TIA or any intracranial pathology in the last six months
8.Major surgery or trauma within the previous six weeks
9.Platelet count <100.000 per cubic mm or HCT ,33% or Hb <11 gm/dL
10.Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization
11.Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban
12.Patients with severe hypertension (SBP>180 mm Hg or DBP >110 mm Hg) or in cardiogenic shock (SBP 80 mm Hg or below for >30 minutes) or requiring IABP

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 600mg clopidogrel) on CK-MB elevation, compared to Aspirin, Heparin and 600mg clopidogrel alone in patients resistant to aspirin and/or clopidogrel.;Secondary Objective: 1. To investigate the relationship between the degree of platelet inhibition reached immediately before intervention and the degree of CK/CK-MB and/or troponin I or T elevation after intervention.<br>2. To investigate the effect of treatment with a high bolus dosage of tirofiban (in addition to Aspirin, Heparin and 600mg clopidogrel) on the incidence of myocardial infarction defined as elevation of CK-MB =3 times the upper limit of normal or cTnI elevation more than =3 times the upper limit of normal and on Thrombotic Bail-out therapy after the start of PCI. <br>;Primary end point(s): degree of periprocedural necrosis after PCI (increase of CK-MB over the normal upper limit)