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)

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03726892
• Other study ID #: IwateMedicalU
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2020
• Source: Iwate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 1, 2022
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Device:
• PCI
Coronary Intervention

Locations

Country	Name	City	State
Japan	Iwate Medical University Hospital	Morioka

Sponsors (1)

Lead Sponsor	Collaborator
Iwate Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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