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

T

The Hospital District of Satakunta

Status

Completed

Conditions

Acute Myocardial Infarction

Treatments

Device: Titan stent and Taxus-Liberte stent

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

425 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

425 participants in 2 patient groups

TITANOX
Experimental group
Description:
Titanium-nitride-oxide coated stent
Treatment:
Device: Titan stent and Taxus-Liberte stent
PES
Active Comparator group
Description:
Paclitaxel-eluting stent
Treatment:
Device: Titan stent and Taxus-Liberte stent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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