Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 425
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis.(One year)