Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction
NCT ID: NCT00495664
Last Updated: 2012-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
425 participants
INTERVENTIONAL
2005-12-31
2009-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TITANOX
Titanium-nitride-oxide coated stent
Titan stent and Taxus-Liberte stent
PES
Paclitaxel-eluting stent
Titan stent and Taxus-Liberte stent
Interventions
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Titan stent and Taxus-Liberte stent
Eligibility Criteria
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Inclusion Criteria
* Wtitten informed consent
Exclusion Criteria
* Unprotected left main disease
* Ostial lesion
* Contraindication to asa, heparins, thienopyridines
* life expectancy \< 12 months
* stent length needed \> 28 mm
18 Years
ALL
No
Sponsors
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The Hospital District of Satakunta
OTHER
Principal Investigators
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Pasi Karjalainen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Satakunta Central Hospital
Locations
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Satakunta Central Hospital
Pori, , Finland
Countries
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References
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Karjalainen PP, Ylitalo A, Niemela M, Kervinen K, Makikallio T, Pietila M, Sia J, Tuomainen P, Nyman K, Airaksinen KE. Two-year follow-up after percutaneous coronary intervention with titanium-nitride-oxide-coated stents versus paclitaxel-eluting stents in acute myocardial infarction. Ann Med. 2009;41(8):599-607. doi: 10.1080/07853890903111018.
Karjalainen PP, Ylitalo A, Niemela M, Kervinen K, Makikallio T, Pietili M, Sia J, Tuomainen P, Nyman K, Airaksinen KE. Titanium-nitride-oxide coated stents versus paclitaxel-eluting stents in acute myocardial infarction: a 12-months follow-up report from the TITAX AMI trial. EuroIntervention. 2008 Aug;4(2):234-41. doi: 10.4244/eijv4i2a42.
Other Identifiers
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SA-002
Identifier Type: -
Identifier Source: org_study_id