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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yoshihiro Morino, Iwate Medical University
ClinicalTrials.gov Identifier:
NCT02014753
First received: December 12, 2013
Last updated: May 26, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease
Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Iwate Medical University:

Primary Outcome Measures:
  • The percentage of stent strut coverage by OCT [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Any Target Lesion Revascularization (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Clinically-driven TLR [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Any Target Vessel Revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Coronary-artery bypass surgery (CABG) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Any revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Angiographic binary restenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patient-oriented composite [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke

  • OCT Endpoint [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: Yes ]
    • 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

  • Angiographic Quantitative analysis [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    • 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

  • Angiographic Qualitative analysis [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    • Peri-stent contrast stain (PSS)
    • Site and pattern of restenosis (based on Mehran classification)


Other Outcome Measures:
  • Platelet Aggregation Test [ Time Frame: At the time of OCT follow-up (2 weeks or 3 months) and 12 month s ] [ Designated as safety issue: Yes ]
    (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.


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014753

Locations
Japan
Iwate Medical University Hospital
Morioka, Japan, 020-8505
Sponsors and Collaborators
Iwate Medical University
  More Information

Responsible Party: Yoshihiro Morino, Professor, Iwate Medical University
ClinicalTrials.gov Identifier: NCT02014753     History of Changes
Other Study ID Numbers: MECHANISM-AMI 
Study First Received: December 12, 2013
Last Updated: May 26, 2016
Health Authority: Japan: Institutional Review Board

Keywords provided by Iwate Medical University:
AMI
STEMI
ACS

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Chromium
Cobalt
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 30, 2016