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)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: PCI

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Morioka, Japan, 020-8505
    • Iwate Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The SYNERGY stent	Device: PCI; Coronary Intervention
Active Comparator: Xience	Device: PCI; Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2-weeks

Collaborators and Investigators

• Sponsor: Iwate Medical University
• Investigators: Principal Investigator: Yoshihiro Morino, MD, Iwate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): May 28, 2020
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease
• Other Study ID Numbers: IwateMedicalU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No