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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03402711

Collaborator

(none)

5,500

Enrollment

Location

39.6

Anticipated Duration (Months)

139

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Percutaneous Coronary Intervention Bleeding

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 14, 2017

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

the incidence of major bleeding during each visit [12 months]
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard;

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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