Bleeding Risk Assessment System for Antithrombotic Therapy of ACS
Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome
1 other identifier
observational
6,379
1 country
1
Brief Summary
Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 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
January 4, 2018
CompletedFirst Submitted
Initial submission to the registry
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 12, 2022
April 1, 2022
5 years
November 12, 2019
April 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The number of event of bleeding
The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment
30 days
The number of event of bleeding
The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment
1 year
Secondary Outcomes (2)
The number of event of bleeding
30 days and 1 year
number of event of major adverse cardiovascular or cerebrovascular events
30 days and 1 year
Eligibility Criteria
ACS patients
You may qualify if:
- Age18-85 years old
- Diagnosed ACS
- Signed informed consent form
You may not qualify if:
- Any active bleeding
- Not tolerate to anti-thrombotic drugs
- A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment
- Patients who died of non-bleeding causes within 24 hours after admission
- Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Anzhen Hospitallead
- Peking Union Medical College Hospitalcollaborator
- Beijing Hospitalcollaborator
- Beijing Luhe Hospitalcollaborator
- Beijing Chao Yang Hospitalcollaborator
Study Sites (1)
Beijing Anzhen Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Director, Emergency & Critical Care Center
Study Record Dates
First Submitted
November 12, 2019
First Posted
November 14, 2019
Study Start
January 4, 2018
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
April 12, 2022
Record last verified: 2022-04