NCT03338335

Brief Summary

this study is an individual patient level meta-analysis of randomized clinical trials, to evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia and bleeding is distinct by ethnicity.

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
16,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

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

Study Start

First participant enrolled

March 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

November 7, 2017

Last Update Submit

February 20, 2018

Conditions

Coronary Artery DiseasePercutaneous Coronary InterventionDual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (2)

  • primary ischemic endpoint

    major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis

    2 years

  • primary bleeding endpoints

    major bleeding events

    2 years

Secondary Outcomes (5)

  • all-cause death

    2 years

  • cardiac death

    2 years

  • non-cardiac death

    2 years

  • any myocardial infarction

    2 years

  • any stroke

    2 years

Interventions

prolonged DAPTDRUG

Dual antiplatelet therapy will be prescribed for more than 12 months

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individual participant data (IPD) meta-analysis of randomized controlled trials designed to investigate the efficacy and safety of shorter duration of DAPT with a longer duration DAPT in patients with ischemic heart diseases.

You may qualify if:

  • patients enrolled in previous RCTs related to the duration of dural antiplatelet agent therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Kang J, Park KW, Palmerini T, Stone GW, Lee MS, Colombo A, Chieffo A, Feres F, Abizaid A, Bhatt DL, Valgimigli M, Hong MK, Jang Y, Gilard M, Morice MC, Park DW, Park SJ, Jeong YH, Park J, Koo BK, Kim HS. Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs. Thromb Haemost. 2019 Jan;119(1):149-162. doi: 10.1055/s-0038-1676545. Epub 2018 Dec 31.

    PMID: 30597509DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

March 1, 2017

Primary Completion

March 31, 2018

Study Completion

October 31, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

KR(1)