Acute Myocardial Infarction Clinical Trial
Official title:
Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction
Coronary-stent implantation is commonly performed for treatment of acute myocardial infarction (MI). Drug eluting stents (DES) among selected patients have been shown to reduce target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). However, there is no studies comparing titanium-nitride-oxide (TITANOX) coated stent with paclitaxel-eluting stent (PES) in acute MI.
Study Design and Patient Population
The TITAX AMI (Titanium-Nitride-Oxide Coated stents versus Paclitaxel-Eluting Stents In
Acute Myocardial Infarction) trial is a prospective, randomized and a multicenter trial
conducted from December 2005 to November 2006 in six Finnish hospitals. The study was
conducted according to the declaration of Helsinki and written informed consent was obtained
from all patients. This protocol was approved by the Ethics Committees of the coordinating
centre Satakunta Central Hospital and the participating hospitals.
Patients > 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this
trial. Exclusion criteria included unprotected left main disease, ostial or restenotic
lesions, contraindication to aspirin, clopidogrel or heparins, life expectancy of less than
12 months and if a stent longer than 28 mm was needed. According to the trial protocol,
randomization was performed after visualization of the culprit lesion or a totally occluded
infarct-related vessel during coronary angiography. Using sealed envelopes, patients were
randomly assigned to the groups in a 1:1 ratio in each participating center.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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