Registry of Bleeding Risk in Real World Chinese Acute Cor... | NCT03402711

Studies
Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II

NCT03402711

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Jan 18, 2018Actual

Enrollment

5,500Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome
Percutaneous Coronary Intervention
Bleeding

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2017Actual

Primary Completion Date

Apr 2020Estimated

Completion Date

Apr 2021Estimated

First Submitted Date

Jan 11, 2018

First Submission Date that Met QC Criteria

Jan 11, 2018

First Posted Date

Jan 18, 2018Actual

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

Jan 11, 2018

Last Update Posted Date

Jan 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yun Dai Chen, Director of the Cardiovascular Department, Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

Detailed Description

Acute coronary syndrome (ACS) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation.

With the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for ACS patients after PCI.Moreover,Bleeding after PCI therapy significantly increased short-term and long-term risk of death.

However, there is a lack of data on the risk of bleeding in ACS patients treated with PCI in the clinical reality world of china.

Therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

This study will provide sufficient and reliable evidence for the risk of bleeding and the choice of antithrombotic drugs in ACS patients undergoing PCI in China, and provide a reference for individual antithrombotic therapy after PCI.

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

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bleeding Risk in Chinese ACS II		1.This is an observational study，there is no intervention to be administered. 2.5500 ACS patients who meet the inclusion criteria for PCI treatment will be consecutively enrolled according to random number sampling.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of major bleeding during each visit	Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard;	12 months

Secondary Outcomes

Measure	Description	Time Frame
the incidence of major adverse cardiovascular events during each visit	Definition of major adverse cardiovascular events（MACE）：Cardiac death, nonfatal myocardial infarction, ischemic stroke, emergency revascularization;	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age≥18 years, male or female;
confirmed acute coronary syndrome patients;
undergo percutaneous coronary intervention (PCI) treatment;
agree to participate in this clinical study and sign a written consent form.

Exclusion Criteria:

ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure;
patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements;
pregnant women or lactating women;
investigators consider patients who were not suitable for participation with other reasons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

The patients must have been diagnosed as ACS and planned to undergo PCI treatment prior to admission, and the investigators have decided to use antithrombotic therapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dandan Li, MD	Contact	+8613810545564		ldd301heart@qq.com
Yundai Chen, MD	Contact	+8613311119778		cyundai@vip.163.com

Overall Officials

Name	Affiliation	Role
Yundai Chen, MD	The General Hospital of PLA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The General Hospital of PLA	Recruiting	Beijing		100853	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D006470	Hemorrhage

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided