Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial InfarctionTreatment of ST-elevation Acute Myocardial Infarction (MECHANISM-AMI)

March 17, 2019 updated by: Yoshihiro Morino, Iwate Medical University

Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial Infarction: MECHANISM-AMI

To treat patients with acute myocardial infarction, primary percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Morioka, Japan, 020-8505
        • Iwate Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

- AMI definition is accordance with the third universal definition of ESC /ACCF/ AHA/ WHF Task Force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn) I or T] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundlebranch block (LBBB).

Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Identification of an intracoronary thrombus by angiography or autopsy Of the AMI patients who met the above definition, the criterial for inclusion is limited to STEMI patients. STEMI is defined as new ST elevation at the J point in at least 2 contiguous leads of equal or greater than2 mm (0.2 mV) in men equal or greater than1.5 mm (0.15 mV) in women in leads V2-V3 and/or of equal or greater than 1 mm (0.1 mV) in other contiguous chest leads or the limb leads

  • Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated.
  • Patients aged 20 to less than 85 years at the time of informed consent
  • Patients who have provided informed consent written by themselves
  • Patients who are able to undergo OCT examinations of the site of stent placement at 2 weeks or 3 months and at 12 months.

Exclusion Criteria:

  • Shock
  • Patients who are judged incapable of undergoing clinical follow-up 12 months after PCI (Consider also the location of patients' residences)
  • Lack of specific findings of ACS by angiography (Left to the operator's decision.)
  • The culprit lesion is the left main coronary trunk
  • Lesion with the reference vascular diameter less than 2.0mm or not less than 4.5mm by visual evaluation.
  • Chronic renal failure with serum creatinine level not less than 2.0mg/dl on hospital visit
  • Patients on hemodialysis Cancer patients whose vital prognosis is expected to be within 2 years. Surgery that requires discontinuation of the antiplatelet agent is scheduled within 3 months
  • Patients who experienced adverse reaction to aspirin or clopidogrel (this shall not apply for patients in whom safety of ticlopidine is confirmed)
  • Patients who took warfarin before the onset
  • Patients under 20 years old
  • Pregnant women
  • AMI due to stent thrombosis at prior stented segment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CoCr-EES, 2-week OCT follow-up
Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 2-week after PCI.
Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)
Other Names:
  • XIENCE PRIME
  • XIENCE Xpedition
CoCr-EES, 3-month OCT follow-up
Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 3-month after PCI.
Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)
Other Names:
  • XIENCE PRIME
  • XIENCE Xpedition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The percentage of stent strut coverage by OCT
Time Frame: 2 weeks
To observe temporal course from the early stage, the rate of stent-strut coverage in the 3-months arm will also be evaluated in a complementary manner, separately from the 2-weeks arm.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding
Time Frame: 1 year
1 year
Any Target Lesion Revascularization (TLR)
Time Frame: 1 year
1 year
Clinically-driven TLR
Time Frame: 1 year
1 year
Any Target Vessel Revascularization (TVR)
Time Frame: 1 year
1 year
Coronary-artery bypass surgery (CABG)
Time Frame: 1 year
1 year
Any revascularization
Time Frame: 1 year
1 year
Angiographic binary restenosis
Time Frame: 1 year
1 year
Patient-oriented composite
Time Frame: 1 year
Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke
1 year
OCT Endpoint
Time Frame: 2 weeks and 3 months
  • The percentage of stent strut malapposition
  • The presence of Intra-stent thrombus
  • Intra-stent thrombus area (Maximum site)
  • Intra-stent thrombus length
  • The number of Intra-stent thrombus
2 weeks and 3 months
Angiographic Quantitative analysis
Time Frame: 12 month
  • In-segment late loss
  • Minimal lumen diameter (MLD), reference vessel diameter (RVD), percent diameter stenosis (%DS)
  • In-stent late loss
  • Binary restenosis (In-stent, In-segment, Peri-stent)
  • Angiographically detected stent fracture（based on Popma's classification ）
  • The number of Intra-stent thrombus
12 month
Angiographic Qualitative analysis
Time Frame: 12 month
  • Peri-stent contrast stain (PSS)
  • Site and pattern of restenosis (based on Mehran classification)
12 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Platelet Aggregation Test
Time Frame: At the time of OCT follow-up (2 weeks or 3 months) and 12 month s
(1) at the time of PCI, (2) at the time of OCT at 2 weeks or 3 months after PCI, (3) at 12-month follow-up, and (4) at the time of occurrence of a cardio-cerebrovascular event.
At the time of OCT follow-up (2 weeks or 3 months) and 12 month s

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iwate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MECHANISM-AMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings