NCT03447379

Brief Summary

To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,452

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable coronary-artery-disease

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

First Submitted

Initial submission to the registry

December 1, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
Last Updated

March 12, 2025

Status Verified

August 1, 2022

Enrollment Period

4.2 years

First QC Date

December 1, 2017

Last Update Submit

March 10, 2025

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Major adverse cardiovascular clinical events (MACCE)

    cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization

    between 3 and 12 month after the procedure

  • Major bleeding

    The Bleeding Academic Research Consortium (BARC) type 3 or 5

    between 3 and 12 month after the procedure

Study Arms (2)

P2Y12 antagonist monotherapy

EXPERIMENTAL

P2Y12 antagonist monotherapy after 3-month DAPT

Drug: P2Y12 antagonist monotherapy

Aspirin + P2Y12 antagonist

ACTIVE COMPARATOR

Aspirin + P2Y12 antagonist after 3-month DAPT

Drug: Aspirin plus P2Y12 antagonist

Interventions

P2Y12 antagonist monotherapyDRUG

P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day)

P2Y12 antagonist monotherapy
Aspirin plus P2Y12 antagonistDRUG

DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year

Aspirin + P2Y12 antagonist

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19+
  • Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
  • Patients who understand the content of the subject description and voluntarily sign the subject

You may not qualify if:

  • Age 86+
  • Hemodynamically unstable patient
  • Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
  • Patients at high risk of bleeding, anemia, thrombocytopenia
  • Patients requiring oral anticoagulants
  • Pregnant women or women of childbearing age
  • Life expectancy is less than one year
  • Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
  • Patients with a history of intracranial hemorrhage
  • Patients with moderate to severe hepatic impairment
  • Patients underwent coronary intervention with stenting within 1 year
  • Patients with left-main lesions requiring coronary intervention
  • Patients with chronic stricture lesions requiring treatment
  • Patients with in-stent restenosis in a lesion requiring treatment
  • Patients with bifurcation lesions requiring stenting in lateral branches
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, Souel, South Korea

Location

Related Publications (1)

  • Min PK, Kang TS, Cho YH, Cheong SS, Kim BK, Kwon SW, Park WJ, Lee JH, Kim W, Lee WS, Yoon YW, Lee BK, Kwon HM, Hong BK; SHARE Investigators. P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e240877. doi: 10.1001/jamanetworkopen.2024.0877.

    PMID: 38451525DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Bumkee Hong

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

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
Professor

Study Record Dates

First Submitted

December 1, 2017

First Posted

February 27, 2018

Study Start

December 15, 2017

Primary Completion

March 3, 2022

Study Completion

August 17, 2022

Last Updated

March 12, 2025

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)