Status:
COMPLETED
Role of Tirofiban and the Paclitaxel Eluting Stent in Postfibrinolysis Angioplasty
Lead Sponsor:
GRACIA Group
Collaborating Sponsors:
Spanish Ministry of Health.
Ministry of Science and Innovation, Spain
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with pacli...
Detailed Description
The primary objectives of this study are: first to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis, and second to determine the effect of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT00306228
Start Date
October 1 2004
End Date
January 1 2009
Last Update
September 28 2009
Active Locations (1)
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1
Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47005