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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402711
• Other study ID #: CLOPIL08731
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 11, 2018
• Start date: December 14, 2017
• Est. completion date: April 2021

Study information

• Verified date: January 2018
• Source: Chinese PLA General Hospital
• Contact: Dandan Li, MD
• Phone: +8613810545564
• Email: ldd301heart[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5500
• Est. completion date: April 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Bleeding
• Hemorrhage
• Percutaneous Coronary Intervention
• Syndrome

Locations

Country	Name	City	State
China	The General Hospital of PLA	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of major bleeding during each visit	Bleeding definition:According to the bleeding Academic Research Congress (BARC) standard;	12 months
Secondary	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