Bleeding Risk Assessment System for Antithrombotic Therapy of ACS

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT04162808
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-04
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-14
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-10
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6379

Inclusion Criteria

1. Age18-85 years old
2. Diagnosed ACS
3. Signed informed consent form

Exclusion Criteria

1. Any active bleeding
2. Not tolerate to anti-thrombotic drugs
3. A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment
4. Patients who died of non-bleeding causes within 24 hours after admission
5. Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
6. Pregnancy or lactation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of event of bleeding	1 year	The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment

Secondary Outcome Measures

Name	Time	Method
The number of event of bleeding	30 days and 1 year	The number of event of bleeding (BARC 1 to 5) within 30 days and 1year after enrollment
number of event of major adverse cardiovascular or cerebrovascular events	30 days and 1 year	number of event of major adverse cardiovascular or cerebrovascular events within 30 days and 1year after enrollment

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China