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

NCT02014753 | Completed

• 1 other identifier: MECHANISM-AMI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

AMI; STEMI; ACS

Outcome Measures

Primary Outcomes (1)

• The percentage of stent strut coverage by OCT

  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 Outcomes (11)

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

  1 year

• Any Target Lesion Revascularization (TLR)

  1 year

• Clinically-driven TLR

  1 year

• Any Target Vessel Revascularization (TVR)

  1 year

• Coronary-artery bypass surgery (CABG)

  1 year

Other Outcomes (1)

• Platelet Aggregation Test

  At the time of OCT follow-up (2 weeks or 3 months) and 12 month s

Study Arms (2)

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)

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)

Interventions

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

Also known as: XIENCE PRIME, XIENCE Xpedition

CoCr-EES, 2-week OCT follow-up; CoCr-EES, 3-month OCT follow-up

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iwate Medical University: lead

Study Sites (1)

Iwate Medical University Hospital

Morioka, 020-8505, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: April 30, 2014
• Primary Completion: September 25, 2015
• Study Completion: July 26, 2016
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

JP (1)