Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction (TITAX AMI)

This study has been completed.
Sponsor:
Information provided by:
The Hospital District of Satakunta
ClinicalTrials.gov Identifier:
NCT00495664
First received: July 2, 2007
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Device: Titan stent and Taxus-Liberte stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by The Hospital District of Satakunta:

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. [ Time Frame: One Year ]

Secondary Outcome Measures:
  • The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis. [ Time Frame: One year ]

Enrollment: 425
Study Start Date: December 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TITANOX
Titanium-nitride-oxide coated stent
Device: Titan stent and Taxus-Liberte stent
Active Comparator: PES
Paclitaxel-eluting stent
Device: Titan stent and Taxus-Liberte stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495664

Locations
Finland
Satakunta Central Hospital
Pori, Finland, 28500
Sponsors and Collaborators
The Hospital District of Satakunta
Investigators
Principal Investigator: Pasi Karjalainen, MD Department of Cardiology, Satakunta Central Hospital
  More Information

No publications provided by The Hospital District of Satakunta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00495664     History of Changes
Other Study ID Numbers: SA-002
Study First Received: July 2, 2007
Last Updated: September 5, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by The Hospital District of Satakunta:
titanium
paclitaxel
stent
myocardial infarction
angioplasty
PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014