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

September 5, 2012 updated by: The Hospital District of Satakunta

Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Pori, Finland, 28500
        • Satakunta Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One Year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital District of Satakunta

Investigators

  • Principal Investigator: Pasi Karjalainen, MD, Department of cardiology, Satakunta Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

July 2, 2007

First Submitted That Met QC Criteria

July 2, 2007

First Posted (Estimate)

July 3, 2007

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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