Status:
COMPLETED
Drug Eluting Stent (DES) in Primary Angioplasty
Lead Sponsor:
San Giuseppe Moscati Hospital
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI) referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is responsible for ...
Eligibility Criteria
Inclusion
- Clinical symptoms of STEMI, with initial onset of chest pain within the past 12 hours, an ECG demonstrating \> 0.1 mV ST-segment elevation in 2 or more contiguous leads or documented new left bundle-branch block and were suitable candidates for percutaneous revascularization.
Exclusion
- Active internal bleeding or a history of bleeding diathesis within the previous 30 days
- An history of intracranial hemorrhage
- Intracranial neoplasm
- Arteriovenous malformation or aneurysm
- Known allergy to sirolimus
- Paclitaxel
- Heparin, aspirin, or clopidogrel
- An history of stroke within 30 days or any history of hemorrhagic stroke
- History, symptoms, or findings suggestive of aortic dissection, fibrinolytic therapy within 24 hours
- History of thrombocytopenia, pregnancy, patients on warfarin or acenocoumarol within the last seven days
- Inability to obtain the informed consent
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00759850
Start Date
October 1 2003
End Date
December 1 2007
Last Update
September 25 2008
Active Locations (1)
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1
U.O. Cardiologia/UTIC
Avellino, Italy, 83100