Bleeding Risk Assessment System for Antithrombotic Therapy of ACS

Overview

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.

Full Title of Study: “Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2022

Clinical Trial Outcome Measures

Primary Measures

  • The number of event of bleeding
    • Time Frame: 30 days
    • The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment
  • The number of event of bleeding
    • Time Frame: 1 year
    • The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment

Secondary Measures

  • The number of event of bleeding
    • Time Frame: 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
    • Time Frame: 30 days and 1 year
    • number of event of major adverse cardiovascular or cerebrovascular events within 30 days and 1year after enrollment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Anzhen Hospital
  • Collaborator
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shao-Ping Nie, Professor of Medicine, Director, Emergency & Critical Care Center – Beijing Anzhen Hospital

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