Registry Study on Drug Therapy and Clinical Outcomes in P... | NCT04184583

Studies
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome

NCT04184583

Sponsor

Beijing Anzhen Hospital

Status

Not yet recruiting

Last Update Posted

Dec 3, 2019Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Drug Therapy
Acute Coronary Syndrome

Interventions

Not provided

Countries

China

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2019Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 28, 2019

First Submission Date that Met QC Criteria

Nov 29, 2019

First Posted Date

Dec 3, 2019Actual

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

Nov 29, 2019

Last Update Posted Date

Dec 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Yang, Director of pharmacy department of Beijing Anzhen Hospital, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
main adverse cardiovascular and cerebrovascular events (MACCE)	MACCE will be defined as all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization.	up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Adverse drug reaction	Adverse drug reaction will be defined as any adverse reactions in the patients.	up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent has been signed.
Patients diagnosed in our hospital with acute coronary syndrome.
Age ≥18.
Life expectancy ≥12 months.

Exclusion Criteria:

Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
Pregnant and lactating women.
Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Acute Coronary Syndrome with blood concentration monitoring or genetic testing at the pharmacy department of Beijing Anzhen Hospital from January 1, 2018.Those who fill the inclusion criteria at screening will be invited for the registry study into different groups.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Zhang, PhD	Contact	86-010-64456609		phd-zhangyi@outlook.com
Yang Lin, PhD	Contact	86-010-64456609		linyang3623@outlook.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital		Beijing	Beijing Municipality	100029	China

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided