Acute Myocardial InfarctionTITAX AMINCT00495664
Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction
A study testing Titan stent and Taxus-Liberte stent in people with Acute Myocardial Infarction, run by The Hospital District of Satakunta at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Titan stent and Taxus-Liberte stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2005to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial.
- Wtitten informed consent
Who cannot join
- Restenosis
- Unprotected left main disease
- Ostial lesion
- Contraindication to asa, heparins, thienopyridines
- life expectancy < 12 months
- stent length needed > 28 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Titan stent and Taxus-Liberte stent
- Keywords
- titanium, paclitaxel, stent, myocardial infarction, angioplasty, PCI
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titan stent and Taxus-Liberte stentDevice
| Study group | Role | What they receive |
|---|---|---|
| TITANOX | Experimental | Titanium-nitride-oxide coated stent Receives: Device: Titan stent and Taxus-Liberte stent |
| PES | Active comparator | Paclitaxel-eluting stent Receives: Device: Titan stent and Taxus-Liberte stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Secondary outcomes (1)
The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startDec 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital District of Satakunta
- Sponsor type
- University, hospital or other
- Investigators
- Pasi Karjalainen, MD, Principal investigator, Department of Cardiology, Satakunta Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495664
- Sponsor's protocol ID
- SA-002
- Acronym
- TITAX AMI
- Status last verified
- Sep 2012
- First submitted
- 2 Jul 2007
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karjalainen PP, Ylitalo A, Niemela M, Kervinen K, Makikallio T, Pietila M, Sia J, Tuomainen P, Nyman K, Airaksinen KE. Two-year follow-up after percutaneous coronary intervention with titanium-nitride-oxide-coated stents versus paclitaxel-eluting stents in acute myocardial infarction. Ann Med. 2009;41(8):599-607. doi: 10.1080/07853890903111018.
PubMed 19701826Karjalainen PP, Ylitalo A, Niemela M, Kervinen K, Makikallio T, Pietili M, Sia J, Tuomainen P, Nyman K, Airaksinen KE. Titanium-nitride-oxide coated stents versus paclitaxel-eluting stents in acute myocardial infarction: a 12-months follow-up report from the TITAX AMI trial. EuroIntervention. 2008 Aug;4(2):234-41. doi: 10.4244/eijv4i2a42.
PubMed 19110789
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00495664
- Acronym / sponsor ID
- TITAX AMI / SA-002
- Conditions
- Acute Myocardial Infarction
- Keywords
- titanium, paclitaxel, stent, myocardial infarction, angioplasty, PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- The Hospital District of SatakuntaUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TITANOX | Experimental | Device: Titan stent and Taxus-Liberte stentTitanium-nitride-oxide coated stent |
| PES | Active comparator | Device: Titan stent and Taxus-Liberte stentPaclitaxel-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients > 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial.
- Wtitten informed consent
Key exclusion criteria (6 listed)
- Restenosis
- Unprotected left main disease
- Ostial lesion
- Contraindication to asa, heparins, thienopyridines
- life expectancy < 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titan stent and Taxus-Liberte stent | Device | PES, TITANOX |
Primary outcome
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
1 secondary outcome
The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Derived from this study: PubMed 19701826Karjalainen PP, Ylitalo A, Niemela M, Kervinen K, Makikallio T, Pietila M, Sia J, Tuomainen P, Nyman K, Airaksinen KE. Two-year follow-up after percutaneous coronary intervention with titanium-nitride-oxide-coated stents versus paclitaxel-eluting stents in acute myocardial infarction. Ann Med. 2009;41(8):599-607. doi: 10.1080/07853890903111018.
- Derived from this study: PubMed 19110789Karjalainen PP, Ylitalo A, Niemela M, Kervinen K, Makikallio T, Pietili M, Sia J, Tuomainen P, Nyman K, Airaksinen KE. Titanium-nitride-oxide coated stents versus paclitaxel-eluting stents in acute myocardial infarction: a 12-months follow-up report from the TITAX AMI trial. EuroIntervention. 2008 Aug;4(2):234-41. doi: 10.4244/eijv4i2a42.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasi Karjalainen, MD principal investigator
Department of Cardiology, Satakunta Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titan stent and Taxus-Liberte stent in people with Acute Myocardial Infarction, run by The Hospital District of Satakunta at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495664, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.