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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)

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ClinicalTrials.gov Identifier: NCT03726892
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Yoshihiro Morino, Iwate Medical University

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: PCI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Everolimus

Arm Intervention/treatment
Active Comparator: The SYNERGY stent Device: PCI
Coronary Intervention

Active Comparator: Xience Device: PCI
Coronary Intervention




Primary Outcome Measures :
  1. 2-weeks strut coverage rate by FD-OCT [ Time Frame: 2-weeks ]
    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.



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Ages Eligible for Study:   20 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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Responsible Party: Yoshihiro Morino, Professor, Iwate Medical University
ClinicalTrials.gov Identifier: NCT03726892     History of Changes
Other Study ID Numbers: IwateMedicalU
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs