Clinical trial NCT03402711: Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II
Official title: Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Bleeding
Keywords: ACS
PCI
Bleeding risk
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 5500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: the incidence of major bleeding during each visit
timeFrame: 12 months
Secondary outcomes:
measure: the incidence of major adverse cardiovascular events during each visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of PLA
Study officials:
affiliation: The General Hospital of PLA
name: Yundai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: