An interventional study of Titan stent and Taxus-Liberte stent in Acute Myocardial Infarction, sponsored by The Hospital District of Satakunta. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-06.
Sponsored by The Hospital District of Satakunta · Not applicable, Interventional, and Treatment
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 425 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →The Hospital District of Satakunta is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Titanium-nitride-oxide coated stent
Device: Titan stent and Taxus-Liberte stent
Paclitaxel-eluting stent
Device: Titan stent and Taxus-Liberte stent
The primary end point was the first occurrence of major adverse cardiac event at 12 months defined as the composite of target lesion revascularization (TLR), recurrent MI, or death from cardiac causes.
Time frame: One Year
The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis.
Time frame: One year
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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The Hospital District of Satakunta