Research of Resistance to Antiplatelet Agents and Develop... | NCT02121054

Studies
Research of Resistance to Antiplatelet Agents and Development of Tailored Treatment Model for Patients With Coronary Artery Disease

NCT02121054

Sponsor

Young-Hak Kim, MD, PhD

Status

Completed

Last Update Posted

Mar 20, 2023Actual

Enrollment

1,527Actual

Phase

Not provided

Conditions

Cardiovascular Diseases
Coronary Artery Disease

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 19, 2013Actual

Primary Completion Date

Oct 29, 2020Actual

Completion Date

Oct 29, 2020Actual

First Submitted Date

Apr 21, 2014

First Submission Date that Met QC Criteria

Apr 22, 2014

First Posted Date

Apr 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the prognosis of patients with resistance to antiplatelet agent and develop tailored treatment model for patients with coronary artery disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,527Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse event	Major adverse event : overall mortality, cardiovascular mortality, target vessel revascularization	2 year

Secondary Outcomes

Measure	Description	Time Frame
Biomarker	homocysteine, Lp(a), fibrinogen, PAI-1, NTpro-BNP, hs-CRP, matrix metalloproteinase-9, soluble CD40L, IL-6, serum amyloid A, AGE	2 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >20
Patients with coronary artery disease
Patients with peripheral artery disease

Exclusion Criteria:

Renal dysfunction
Hepatic dysfunction
Major surgery planned within 1 year
Malignant tumor
History of gastrointestinal bleeding
low or high platelet count

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with coronary artery disease, Patients with peripheral artery disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul	Songpa-Gu		South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided