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

IVERSITA' DEGLI STUDI DI FERRARA0 个研究点目标入组 250 人开始时间: 2008年3月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

IVERSITA' DEGLI STUDI DI FERRARA