Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II
1 other identifier
observational
5,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2017
CompletedFirst Submitted
Initial submission to the registry
January 11, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedJanuary 18, 2018
January 1, 2018
2.3 years
January 11, 2018
January 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of major bleeding during each visit
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard;
12 months
Secondary Outcomes (1)
the incidence of major adverse cardiovascular events during each visit
12 months
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The General Hospital of PLA
Beijing, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yundai Chen, MD
The General Hospital of PLA
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Cardiovascular Department
Study Record Dates
First Submitted
January 11, 2018
First Posted
January 18, 2018
Study Start
December 14, 2017
Primary Completion
April 1, 2020
Study Completion
April 1, 2021
Last Updated
January 18, 2018
Record last verified: 2018-01