Role of Tirofiban and the Paclitaxel Eluting Stent in Postfibrinolysis Angioplasty (GRACIA3)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring ST elevation acute myocardial infarction, Thrombolysis, Early routine percutaneous coronary intervention, tirofiban, paclitaxel
Eligibility Criteria
Inclusion Criteria: Patients with ST-segment elevation acute myocardial infarction with all of the following criteria will be eligible for enrollment: Age >18 years. Chest discomfort >30 minutes with no response to nitroglycerin. Time from the onset of symptoms to randomization < 12 hours. ST segment elevation > 1 mm in two or more limb leads or 2 mm in two or more contiguous precordial leads or non-diagnostic ECG (left bundle branch block or pacemaker rhythm) with classic symptoms. Killip class > 3. Written informed consent will be obtained. Exclusion Criteria: Patients presenting with any of the following will not be included in the study. Cardiogenic shock defined as a systolic blood pressure <90 mm Hg without response to fluid administration or <100 mmHg in patients with supportive treatment and no bradycardia. Suspected mechanical complications of acute myocardial infarction. Previous CABG. Non-cardiac disease that is likely to jeopardize the planned termination of the study. Woman of childbearing potential unless a negative pregnant test. Active bleeding and recent (within 2 weeks) surgery that contraindicate the use of heparin, tirofiban, or platelet aggregation inhibitors. Contraindications for thrombolytic use. previous hemorrhagic stroke at any time history of prior non-hemorrhagic cerebrovascular accident within 12 months intracerebral neoplasia active internal bleeding suspected aortic dissection Uncontrolled hypertension >180/110 in several measurements any other known intracerebral pathology not covered in contraindications Current use of anticoagulants or heparin use within 8 hours known bleeding diathesis recent trauma (< 4 weeks), including head trauma or traumatic or prolonged (>10 minutes) CPR or recent major surgery or biopsy (<8 weeks) noncompressible vascular punctures recent (< 4 weeks) internal bleeding pregnancy active peptic ulcer History of hypersensitivity to aspirin, ticlopidine, clopidogrel, heparin, tirofiban and stainless steel. Known renal failure, creatinine >2,5 mg/dL. Known impaired hepatic function that contraindicates the use of clopidogrel. Known thrombocytopenia (100.000). Participation in other trial. Known multivessel disease identified as no suitable for revascularization. Known peripheral vascular disease that difficult cardiac catheterization.
Sites / Locations
- Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
bare-metal stent without tirofiban
bare-metal stent with tirofiban
paclitaxel-eluting stent without tirofiban
paclitaxel-eluting stent with tirofiban
implantation of a bare-metal stent with no tirofiban infusion after fibrinolysis
implantation of a bare-metal stent with tirofiban infusion after fibrinolysis
implantation of a paclitaxel eluting-stent with no tirofiban after fibrinolysis
implantation of a paclitaxel eluting-stent with tirofiban infusion after fibrinolysis