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

• Conditions: Percutaneous Coronary Intervention; Bleeding; Acute Coronary Syndrome

• Registration Number: NCT03402711
• Lead Sponsor: Chinese PLA General Hospital

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.

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 Timeline

• Study Start: 2017-12-14
• Status Verified: 2018-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Study First Posted: 2018-01-18
• Last Update Posted: 2018-01-18
• Primary Completion: 2020-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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;

Trial Locations

Locations (1)

The General Hospital of PLA; 🇨🇳 Beijing, China