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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 6379

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ACS patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Peking Union Medical College Hospital; Beijing Chao Yang Hospital; Beijing Hospital; Beijing Luhe Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: bleeding; antithrombosis
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Hemorrhage; Acute Coronary Syndrome
• Other Study ID Numbers: 2018055X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No