NCT04570345

Brief Summary

To compare the clinical outcomes of dual antiplatelet therapy with aspirin and P2Y12 receptor inhibitor vs. ticagrelor monotherapy at 3 months after PCI in patients with ST-elevation myocardial infarction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,002

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

September 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

September 25, 2020

Last Update Submit

December 18, 2020

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

  • NACE: net clinical adverse event

    The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score)

    12 months after randomization

  • Major adverse cardiac and cerebrovaascular event(MACCE)

    Major adverse cardiac and cerebrovaascular event(MACCE) includes 1)all-cause motality, 2) acute MI, 3)cerebrovascular event, 4)stent thrombosis

    12 months after randomization

  • Major bleeding (BARC type 3,5)

    The number of participants with first occurrence of clinically relevant bleeding episode, defined as Bleeding Academic Research Consortium (BARC) Types 3 or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding). type 3a: Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding, type 3b: Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents, type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision, type 5a: Probable fatal bleeding, type 5b: Definite fatal bleeding (overt or autopsy or imaging confirmation in accordance with BARC Definitions

    12 months after randomization

Secondary Outcomes (1)

  • Individual component of MACCE and bleeding episode

    12 months after randomization

Study Arms (2)

Ticagrelor monotherapy

EXPERIMENTAL

Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor)

Drug: ticagrelor monotherapy

Aspirin with P2Y12 receptor inhibitor

ACTIVE COMPARATOR

Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor)

Drug: ticagrelor monotherapyDrug: Aspirin with P2Y12 receptor inhibitor

Interventions

ticagrelor monotherapyDRUG

• Drug: ticagrelor monothearpy after first 3 months dual therapy

Also known as: Study group
Aspirin with P2Y12 receptor inhibitorTicagrelor monotherapy
Aspirin with P2Y12 receptor inhibitorDRUG

• Drug: aspirin plus ticagrelor dual therapy during 12 months

Also known as: Control group
Aspirin with P2Y12 receptor inhibitor

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 19 years old
  • Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS
  • Provision of informed consent

You may not qualify if:

  • Age \> 80 years
  • Pregnant women or women with potential childbearing
  • Life expectancy \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine,Dong-A University College of Medicine

Busan, South Korea

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

AspirinControl Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Kyungil Park, Ph.D

    Dong-A University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyungil Park, Ph.D

CONTACT

82-51-240-2733cardiopark@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 25, 2020

First Posted

September 30, 2020

Study Start

January 1, 2021

Primary Completion

August 31, 2021

Study Completion

August 1, 2022

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

KR(1)