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OpenTrials
Completed

NCT Number: NCT02014753

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cobalt-chromium everolimus-eluting stent (CoCr-EES)

Device

Other names: XIENCE PRIME, XIENCE Xpedition

Primary outcomes

  1. 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.

Secondary outcomes

  1. All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding

    Time frame: 1 year

  2. Any Target Lesion Revascularization (TLR)

    Time frame: 1 year

  3. Clinically-driven TLR

    Time frame: 1 year

  4. Any Target Vessel Revascularization (TVR)

    Time frame: 1 year

  5. Coronary-artery bypass surgery (CABG)

    Time frame: 1 year

  6. Any revascularization

    Time frame: 1 year

  7. Angiographic binary restenosis

    Time frame: 1 year

  8. Patient-oriented composite

    Time frame: 1 year

    Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke

  9. 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
  10. 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
  11. Angiographic Qualitative analysis

    Time frame: 12 month

    • Peri-stent contrast stain (PSS)
    • Site and pattern of restenosis (based on Mehran classification)

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Iwate Medical University

Other

Registry information

Official study 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

Acronym: MECHANISM-AMI

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 18, 2013
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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