Multicenter Randomized Comparison of Early Vascular Responses Between Everolimus-eluting Cobalt-chromium Stent and Identically Designed Bare-Metal Stent in Patients With Acute Myocardial Infarction (MECHANISM-AMI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Iwate Medical University
Sponsor:
Information provided by (Responsible Party):
Yoshihiro Morino, Iwate Medical University
ClinicalTrials.gov Identifier:
NCT02014753
First received: December 12, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

To evaluate early vessel response between current standard drug-eluting stent and bare-metal stent in acute myocardial infarction (AMI) patients by optical coherence tomography (OCT).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Comparison of Early Vascular Responses Between Everolimus-eluting Cobalt-CHromium Stent ANd Identically DeSigned Bare-Metal Stent in Patients With Acute Myocardial Infarction: MECHANISM-AMI

Resource links provided by NLM:


Further study details as provided by Iwate Medical University:

Primary Outcome Measures:
  • Primary endpoint: The percentage of stent strut coverage by OCT at 2-week (The percentage of stent strut coverage at 4-week is primary intended to verify the "temporal course" ) The percentage of stent strut coverage by OCT [ Time Frame: 2-week ] [ Designated as safety issue: Yes ]
    The percentage of stent strut coverage at 4-week is primary intended to verify the "temporal course"


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: 8 month ] [ 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 4-weeks ] [ Designated as safety issue: No ]
    • 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: 10±2 months ] [ 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: 10±2 months ] [ Designated as safety issue: No ]
    • Peri-stent contrast stain (PSS)
    • Site and pattern of restenosis (based on Mehran classification)


Estimated Enrollment: 180
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Active Comparator: BMS, 2-week OCT follow up
Undergo primary PCI with bare metal stent (BMS) for AMI culprit lesion and perform OCT observation at 2-week after PCI.
Device: bare metal stent (BMS)
Other Name: MULTI-LINK 8
Active Comparator: CoCr-EES, 4-week OCT follow-up
Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 4-week after PCI.
Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)
Other Names:
  • XIENCE PRIME
  • XIENCE Xpedition
Active Comparator: BMS, 4-week OCT follow-up
Undergo primary PCI with bare metal stent (BMS) for AMI culprit lesion and perform OCT observation at 4-week after PCI.
Device: bare metal stent (BMS)
Other Name: MULTI-LINK 8

Detailed Description:

For primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) patients with elevated cardiac troponin, XIENCE PRIME/Xpedition, a current standard drug-eluting stent (DES), and MULTI-LINK 8, a bare-metal stent with the same design as XIENCE PRIME/Xpedition, were randomly allocated in the ratio of 1:1, to compare the vessel response of the stented segment by optical coherence tomography (OCT), and to clarify the mechanisms of action and characteristics of these stents in AMI patients with elevated cardiac troponin. OCT observation timing was also randomly allocated in 2-weeks and 4-weeks after stent implantation.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 bundle branch 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

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 Not yet recruiting
Morioka, Japan, 020-8505
Contact: Yoshihiro Morino, Professor         
Principal Investigator: Yoshihiro Morino, Professor         
Sponsors and Collaborators
Iwate Medical University
  More Information

No publications provided

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: December 18, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Iwate Medical University:
AMI
STEMI
ACS

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

ClinicalTrials.gov processed this record on August 18, 2014