Bleeding Risk Assessment System for Antithrombotic Therapy of ACS

NCT ID: NCT04162808

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6379 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-04

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Luhe Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shao-Ping Nie

Professor of Medicine, Director, Emergency & Critical Care Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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2018055X

Identifier Type: -

Identifier Source: org_study_id

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