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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04162808

Enrollment

6379

Registered

2019-11-14

Start date

2018-01-04

Completion date

2023-12-31

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

bleeding, antithrombosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The number of event of bleeding	30 days	The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results