Pacientes con enfermedad coronaria que van a someterse a una intervención coronaria percutánea. Patients with coronary disease undergoing percutaneous coronary intervention MedDRA version: 9.1 Level: LLT Classification code 10011099 Term: Coronary disease
Conditions
Interventions
Trade Name: Agrastat
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TIROFIBAN HYDROCHLORIDE
CAS Number: 142373602
Concentration unit: µg/kg microgram(s)/kilogram
Concentration type: n
Sponsors
UNIVERSITA' DEGLI STUDI DI FERRARA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1.Patients who can not give informed consent or have a life expectancy of 180 mm Hg or DBP >110 mm Hg) or in cardiogenic shock (SBP 80 mm Hg or below for >30 minutes) or requiring IABP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. ;Primary end point(s): degree of periprocedural necrosis after PCI (increase of CK-MB over the normal upper limit) | — |
Countries
Spain
Outcome results
None listed