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

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Device: Titan stent and Taxus-Liberte stent

• Registration Number: NCT00495664
• Lead Sponsor: The Hospital District of Satakunta

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-07-02
• Study First Submitted QC: 2007-07-02
• Study First Posted: 2007-07-03
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TITANOX	Titan stent and Taxus-Liberte stent	Titanium-nitride-oxide coated stent
PES	Titan stent and Taxus-Liberte stent	Paclitaxel-eluting stent

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Satakunta Central Hospital; 🇫🇮 Pori, Finland