NCT04848766

Brief Summary

We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies.

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
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

April 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

April 10, 2021

Last Update Submit

June 7, 2021

Conditions

Keywords

percutaneous coronary interventiondual antiplatelet therapyde-escalation

Outcome Measures

Primary Outcomes (1)

  • Net adverse clinical and cerebral events (NACCE)

    composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.

    1 year after intervention

Secondary Outcomes (9)

  • Composite endpoint of Major adverse cardiovascular outcomes

    1 year after intervention

  • Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria

    1 year after intervention

  • Individual components of the primary outcome

    1 year after intervention

  • Individual components of the primary outcome

    1 year after intervention

  • Individual components of the primary outcome

    1 year after intervention

  • +4 more secondary outcomes

Study Arms (2)

De-escalation treatment group

Patients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention

Drug: De-escalation Treatment Strategy of dual antiplatelet therapy

Conventional treatment group

Patients diagnosed as acute coronary syndrome, and who receive conventional (non-de-escalation) antiplatelet therapy after percutaneous coronary intervention

Interventions

Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention

De-escalation treatment group

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As above

You may qualify if:

  • Subject must have clinical diagnosis of acute coronary syndrome

You may not qualify if:

  • The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Kyung Woo Park, MD, PhD

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Hyo-Soo Kim, MD, PhD

CONTACT

Jeehoon Kang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 19, 2021

Study Start

June 7, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations