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Comparison of MECHANISM of Early and Late Vascular Responses Following Treatment of ST-elevation Acute Myocardial Infarction With Two Different Everolimus-eluting Stents: Randomized Controlled Trial Between Biodegradable Polymer and Durable Polymer Stent (MECHANISM-AMI-RCT)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
PCI
Sponsored by
Iwate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with new coronary lesion indicated for PCI using DES
  2. Patients whose age at acquisition of consent is 20 to less than 85 years
  3. Patients who themselves or whose representatives showed the written consent
  4. Patients who will undergo cardiac catheterization 2 weeks later (staged PCI on the other vessel or confirmatory angiography at the treated site)

Exclusion Criteria:

If the following exclusion criteria are satisfied, the patient should not be enrolled in this study even after acquisition of patient's consent:

  1. When the follow-up after 12 months is considered difficult (the patient's residence should also be considered)
  2. When there is no obvious ACS finding in angiography (decisions should be left to operator)
  3. Patients with shock
  4. Patients whose culprit lesion is the left main coronary trunk
  5. Lesion with the reference vascular diameter of <2.0 mm or ≥4.5 mm visually
  6. AMI that occurred newly at the site where a stent has already been placed
  7. Chronic renal failure in which the serum creatinine concentration at visit is ≥2.0 mg/dL
  8. Patients undergoing hemodialysis
  9. Tumor-bearing patients whose life prognosis is expected to be within 2 years
  10. Patients for whom the surgical operation requiring withdrawal of antiplatelet drug is scheduled within 3 months
  11. Female patients during pregnancy or scheduled to be pregnant
  12. Patients with a past history of the side effect of aspirin, clopidogrel or prasugrel (when the patient is confirmed for the safety of ticlopidine, this does not apply even if there is the side effect of clopidogrel or prasugrel)

Sites / Locations

  • Iwate Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The SYNERGY stent

Xience

Arm Description

Outcomes

Primary Outcome Measures

2-weeks strut coverage rate by FD-OCT
In this clinical study, the 2-week covered strut rate by FD-OCT should be considered the primary endpoint, and the non-inferiority of Synergy® to the present standard treatment, Xience®, established in the control group in the treatment of STEMI, should be demonstrated.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2018
Last Updated
May 29, 2020
Sponsor
Iwate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03726892
Brief Title
Comparison of MECHANISM of Early and Late Vascular Responses Following Treatment of ST-elevation Acute Myocardial Infarction With Two Different Everolimus-eluting Stents: Randomized Controlled Trial Between Biodegradable Polymer and Durable Polymer Stent (MECHANISM-AMI-RCT)
Official Title
Comparison of MECHANISM of Early and Late Vascular Responses Following Treatment of ST-elevation Acute Myocardial Infarction With Two Different Everolimus-eluting Stents: Randomized Controlled Trial Between Biodegradable Polymer and Durable Polymer Stent
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iwate Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To place two different everolimus-eluting stents (EES), a bioabsorbable polymer EES (Synergy®) and a permanent-type polymer EES (Xience®), randomly to the ST-elevation acute myocardial infarction (AMI) and to observe and compare the early and chronic vascular responses using the frequency domain optical coherence tomography (FD-OCT). The primary endpoint is the 2-week strut coverage rate by FD-OCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The SYNERGY stent
Arm Type
Active Comparator
Arm Title
Xience
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PCI
Intervention Description
Coronary Intervention
Primary Outcome Measure Information:
Title
2-weeks strut coverage rate by FD-OCT
Description
In this clinical study, the 2-week covered strut rate by FD-OCT should be considered the primary endpoint, and the non-inferiority of Synergy® to the present standard treatment, Xience®, established in the control group in the treatment of STEMI, should be demonstrated.
Time Frame
2-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with new coronary lesion indicated for PCI using DES Patients whose age at acquisition of consent is 20 to less than 85 years Patients who themselves or whose representatives showed the written consent Patients who will undergo cardiac catheterization 2 weeks later (staged PCI on the other vessel or confirmatory angiography at the treated site) Exclusion Criteria: If the following exclusion criteria are satisfied, the patient should not be enrolled in this study even after acquisition of patient's consent: When the follow-up after 12 months is considered difficult (the patient's residence should also be considered) When there is no obvious ACS finding in angiography (decisions should be left to operator) Patients with shock Patients whose culprit lesion is the left main coronary trunk Lesion with the reference vascular diameter of <2.0 mm or ≥4.5 mm visually AMI that occurred newly at the site where a stent has already been placed Chronic renal failure in which the serum creatinine concentration at visit is ≥2.0 mg/dL Patients undergoing hemodialysis Tumor-bearing patients whose life prognosis is expected to be within 2 years Patients for whom the surgical operation requiring withdrawal of antiplatelet drug is scheduled within 3 months Female patients during pregnancy or scheduled to be pregnant Patients with a past history of the side effect of aspirin, clopidogrel or prasugrel (when the patient is confirmed for the safety of ticlopidine, this does not apply even if there is the side effect of clopidogrel or prasugrel)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshihiro Morino, MD
Organizational Affiliation
Iwate Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iwate Medical University Hospital
City
Morioka
ZIP/Postal Code
020-8505
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Comparison of MECHANISM of Early and Late Vascular Responses Following Treatment of ST-elevation Acute Myocardial Infarction With Two Different Everolimus-eluting Stents: Randomized Controlled Trial Between Biodegradable Polymer and Durable Polymer Stent (MECHANISM-AMI-RCT)

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