Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction (TITAX AMI)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Titan stent and Taxus-Liberte stent
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring titanium, paclitaxel, stent, myocardial infarction, angioplasty, PCI
Eligibility Criteria
Inclusion Criteria:
- Patients > 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial.
- Wtitten informed consent
Exclusion Criteria:
- Restenosis
- Unprotected left main disease
- Ostial lesion
- Contraindication to asa, heparins, thienopyridines
- life expectancy < 12 months
- stent length needed > 28 mm
Sites / Locations
- Satakunta Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TITANOX
PES
Arm Description
Titanium-nitride-oxide coated stent
Paclitaxel-eluting stent
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis.
Full Information
NCT ID
NCT00495664
First Posted
July 2, 2007
Last Updated
September 5, 2012
Sponsor
The Hospital District of Satakunta
1. Study Identification
Unique Protocol Identification Number
NCT00495664
Brief Title
Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction
Acronym
TITAX AMI
Official Title
Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Hospital District of Satakunta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
titanium, paclitaxel, stent, myocardial infarction, angioplasty, PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
425 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TITANOX
Arm Type
Experimental
Arm Description
Titanium-nitride-oxide coated stent
Arm Title
PES
Arm Type
Active Comparator
Arm Description
Paclitaxel-eluting stent
Intervention Type
Device
Intervention Name(s)
Titan stent and Taxus-Liberte stent
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial.
Wtitten informed consent
Exclusion Criteria:
Restenosis
Unprotected left main disease
Ostial lesion
Contraindication to asa, heparins, thienopyridines
life expectancy < 12 months
stent length needed > 28 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasi Karjalainen, MD
Organizational Affiliation
Department of Cardiology, Satakunta Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satakunta Central Hospital
City
Pori
ZIP/Postal Code
28500
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19701826
Citation
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.
Results Reference
derived
PubMed Identifier
19110789
Citation
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.
Results Reference
derived
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Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction
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