ST-elevation Acute Myocardial InfarctionXIENCE STEMINCT02792920
Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction
A study testing CoCr-EES in people with ST-elevation Acute Myocardial Infarction and STEMI, run by Hyogo Brain and Heart Center at 2 sites in Japan.
Trial summary
To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES. Also, OCT sub-analysis will be conducted Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ST-elevation Acute Myocardial Infarction, STEMI
- What is being tested?
- CoCr-EES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesJapan
- Study dates
- Mar 2016to Apr 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with STEMI who are able to undergo CoCr-EES implantation.
- Patients with no history of PCI in the target vessel
- Patients who are 20 or older at the time of informed consent
- Patients who provided written informed consent by himself/herself
- Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES
- Patients for whom thrombus aspiration prior to CoCr-EES implantation can be recommended
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- Patients who meet all the following vascular inclusion criteria i.Patients with target lesion in native coronary artery ii.Patients with visual maximum vessel diameter of the target stent site in target lesion
- Patients were obtained finally revascularization of TIMI 3 by visual observation in the target vessel
- Patients who are able to treat with CoCr-EES the diameter 2.5mm or more and 3.5mm or less and the length of 8mm or more and 28mm or less.
Who cannot join
- Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study.
- Patients presenting with cardiogenic shock
- Patients for whom 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account)
- Patients with responsible lesion in left main trunk
- Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit
- Patients on hemodialysis
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- Patients with a known history of adverse drug reactions to aspirin, or clopidogrel or prasugrel (This may not apply if safety of ticlopidine is confirmed as an alternative drug.)
- Patients who are below the age of 20
- Women who were positive in pregnancy test or wish to become pregnant during study duration
- Patients who newly developed AMI attributable to the prior stented site
- Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES
- Patients diagnosed with hepatic insufficiency
- Patients with target lesion in saphenous vein graft
- Patients with active malignant tumor
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Recruiting
Hyogo Brain and Heart Center
Himeji, Hyogo,, 6700981
Yoshinori Yasaka, M.D., +81-79-293-3131
- Recruiting
Higashi Takarazuka Sato Hospital
Takarazuka, Hyogo, 6650873
Satoru Otsuji, M.D., +81-797-88-2200
About this study
To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES.
Also, OCT sub-analysis will be conducted
- Conditions
- ST-elevation Acute Myocardial Infarction, STEMI
- Being tested
- CoCr-EES
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoCr-EESDevice
| Study group | Role | What they receive |
|---|---|---|
| CoCr-EES | Other | Not described Receives: Device: CoCr-EES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure (TVF)
Target vessel failure (TVF) at 12 months after CoCr-EES implantation. TVF consists of defined as cardiac death, target vessel-related recurrent myocardial infarction (MI) or Target Lesion Revascularization (TLR)
Measured: 12 months
Secondary outcomes (6)
MI (QMI and Non-QMI)
Measured: 12 months
Any TLR
Measured: 12 months and 36 months
Any Target Vessel Revascularization (TVR)
Measured: 12 months and 36 months
Death
Measured: 12 months and 36 months
MACE (Cardiac death, MI and TLR)
Measured: 12 months and 36 months
Definite or Probable stent thrombosis
Measured: 12 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyogo Brain and Heart Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792920
- Sponsor's protocol ID
- XIENCE STEMI Registry
- Acronym
- XIENCE STEMI
- Status last verified
- Jun 2016
- First submitted
- 2 Mar 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02792920
- Acronym / sponsor ID
- XIENCE STEMI / XIENCE STEMI Registry
- Conditions
- ST-elevation Acute Myocardial Infarction, STEMI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hyogo Brain and Heart CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 8 Jun 2016 (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.
To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES.
Also, OCT sub-analysis will be conducted
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoCr-EES | Other | Device: CoCr-EES |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with STEMI who are able to undergo CoCr-EES implantation.
- Patients with no history of PCI in the target vessel
- Patients who are 20 or older at the time of informed consent
- Patients who provided written informed consent by himself/herself
- Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES
Key exclusion criteria (14 listed)
- Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study.
- Patients presenting with cardiogenic shock
- Patients for whom 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account)
- Patients with responsible lesion in left main trunk
- Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit
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 |
|---|---|---|
| CoCr-EES | Device | CoCr-EES |
Primary outcome
Target vessel failure (TVF)
Time frame: 12 months
Target vessel failure (TVF) at 12 months after CoCr-EES implantation. TVF consists of defined as cardiac death, target vessel-related recurrent myocardial infarction (MI) or Target Lesion Revascularization (TLR)
6 secondary outcomes
MI (QMI and Non-QMI)
Time frame: 12 months
Any TLR
Time frame: 12 months and 36 months
Any Target Vessel Revascularization (TVR)
Time frame: 12 months and 36 months
Death
Time frame: 12 months and 36 months
MACE (Cardiac death, MI and TLR)
Time frame: 12 months and 36 months
Definite or Probable stent thrombosis
Time frame: 12 months and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoCr-EES in people with ST-elevation Acute Myocardial Infarction and STEMI, run by Hyogo Brain and Heart Center at 2 sites in Japan.
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoshinori Yasaka, M.D. (+81-79-293-3131, yoshiysk@yahoo.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (TVF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2016.