Bleeding Risk Assessment System for Antithrombotic Therapy of ACS

Acute Coronary Syndrome Clinical Trial

Official title:

Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04162808
• Other study ID #: 2018055X
• Status: Active, not recruiting
• Start date: January 4, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6379
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Hemorrhage
• Syndrome

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Chao Yang Hospital, Beijing Hospital, Beijing Luhe Hospital, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of event of bleeding	The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment	30 days
Primary	The number of event of bleeding	The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment	1 year
Secondary	The number of event of bleeding	The number of event of bleeding (BARC 1 to 5) within 30 days and 1year after enrollment	30 days and 1 year
Secondary	number of event of major adverse cardiovascular or cerebrovascular events	number of event of major adverse cardiovascular or cerebrovascular events within 30 days and 1year after enrollment	30 days and 1 year