NCT03440801

Brief Summary

This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing such as the frequency of malapposed and uncovered stent struts at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

7.1 years

First QC Date

February 12, 2018

Last Update Submit

August 31, 2025

Conditions

STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Frequency of neoatheroslcerosis

    Frequency of neoatherosclerosis lesion which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of ≧ 1 mm at three years.

    3 years

Secondary Outcomes (1)

  • Athero-thrombotic material area

    initial day

Study Arms (2)

Synergy

EXPERIMENTAL

Biodegradable-polymer everolimus-eluting stent Synergy

Device: SynergyDevice: Xience

Xience

ACTIVE COMPARATOR

Durable-polymer everolimus-eluting stent Xience

Device: SynergyDevice: Xience

Interventions

SynergyDEVICE

Biodegradable-polymer everolimus-eluting stent Synergy

SynergyXience
XienceDEVICE

Durable-polymer everolimus-eluting stent Xience

SynergyXience

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Primary PCI within 24 hours of symptom onset
  • ST-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguuoius anterior leads
  • Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents

You may not qualify if:

  • Female ofchildbearing potential (age \< 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
  • Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material
  • Inability to understand and provide informed consent
  • Currently participating in another trial before reaching first endpoint
  • Mechanical complications of acute myocardial infarction
  • Acute myocardial infarction secondary to stent thrombosis or restenosis
  • Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
  • Noncardiac comorbid conditions are present with life expectancy \<3years or that may result in protocol noncompliance
  • History of bleeding diathesis or known coagulopathy
  • Use of oral anticoagulation
  • Age \>90 years
  • LV-function at index procedure \<=20%
  • Cancer under active treatment (chemotherapy)
  • Hemodynamic instability following primary PCI
  • Chronic kidey disease (Creatinine - Clearance \< 30ml/min)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokorozawa Heart Center

Tokorozawa, 3591142, Japan

Location

Related Publications (1)

  • Haner JD, Kakizaki R, Taniwaki M, Ohno Y, Yahagi K, Higuchi Y, Siontis GCM, Ando K, Stortecky S, Suzuki N, Watanabe N, Lanz J, Ueki Y, Otsuka T, Biccire FG, Sakurada M, Koskinas KC, Losdat S, Raber L. Low-Density Lipoprotein Cholesterol Levels and Neoatherosclerosis After STEMI: A Secondary Analysis of the CONNECT Randomized Clinical Trial. JAMA Cardiol. 2025 Dec 17:e254723. doi: 10.1001/jamacardio.2025.4723. Online ahead of print.

    PMID: 41405905DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 22, 2018

Study Start

July 3, 2017

Primary Completion

July 30, 2024

Study Completion

September 1, 2024

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations

JP(1)