Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction
TITAX AMI
1 other identifier
interventional
425
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedSeptember 6, 2012
September 1, 2012
3.9 years
July 2, 2007
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
One Year
Secondary Outcomes (1)
The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis.
One year
Study Arms (2)
TITANOX
EXPERIMENTALTitanium-nitride-oxide coated stent
PES
ACTIVE COMPARATORPaclitaxel-eluting stent
Interventions
Eligibility Criteria
You may qualify if:
- Patients \> 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial.
- Wtitten informed consent
You may not qualify if:
- Restenosis
- Unprotected left main disease
- Ostial lesion
- Contraindication to asa, heparins, thienopyridines
- life expectancy \< 12 months
- stent length needed \> 28 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Satakunta Central Hospital
Pori, 28500, Finland
Related Publications (2)
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.
PMID: 19701826DERIVEDKarjalainen 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.
PMID: 19110789DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pasi Karjalainen, MD
Department of Cardiology, Satakunta Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 3, 2007
Study Start
December 1, 2005
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
September 6, 2012
Record last verified: 2012-09