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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03402711

Enrollment

5500

Registered

2018-01-18

Start date

2017-12-14

Completion date

2021-04-30

Last updated

2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Bleeding, Percutaneous Coronary Intervention

Keywords

ACS, PCI, Bleeding risk

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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;

Countries

China

Contacts

Primary ContactDandan Li, MD

ldd301heart@qq.com+8613810545564

Backup ContactYundai Chen, MD

cyundai@vip.163.com+8613311119778

Outcome results