Coronary Artery DiseaseNCT03726892
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)
A study testing PCI in people with Coronary Artery Disease, run by Iwate Medical University at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- 12 Nov 2018to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Coronary Artery Disease
- Being tested
- PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIDevice
Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| The SYNERGY stent | Active comparator | Not described Receives: Device: PCI |
| Xience | Active comparator | Not described Receives: Device: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start12 Nov 2018
- Primary completion28 May 2020
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iwate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihiro Morino, Iwate Medical University
- Investigators
- Yoshihiro Morino, MD, Principal investigator, Iwate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726892
- Sponsor's protocol ID
- IwateMedicalU
- Status last verified
- May 2020
- First submitted
- 30 Oct 2018
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03726892
- Acronym / sponsor ID
- IwateMedicalU
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Iwate Medical UniversityUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The SYNERGY stent | Active comparator | Device: PCI |
| Xience | Active comparator | Device: PCI |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCICoronary Intervention | Device | The SYNERGY stent, Xience |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihiro Morino, MD principal investigator
Iwate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in people with Coronary Artery Disease, run by Iwate Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-weeks strut coverage rate by FD-OCT (time frame: 2-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.