Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II

NCT ID: NCT03402711

Last Updated: 2018-01-18

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

5500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-14

Study Completion Date

2021-04-30

Brief Summary

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The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

Detailed Description

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Acute coronary syndrome (ACS) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation.

With the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for ACS patients after PCI.Moreover,Bleeding after PCI therapy significantly increased short-term and long-term risk of death.

However, there is a lack of data on the risk of bleeding in ACS patients treated with PCI in the clinical reality world of china.

Therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.

This study will provide sufficient and reliable evidence for the risk of bleeding and the choice of antithrombotic drugs in ACS patients undergoing PCI in China, and provide a reference for individual antithrombotic therapy after PCI.

Conditions

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Acute Coronary Syndrome Percutaneous Coronary Intervention Bleeding

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Bleeding Risk in Chinese ACS II

1.This is an observational study,there is no intervention to be administered. 2.5500 ACS patients who meet the inclusion criteria for PCI treatment will be consecutively enrolled according to random number sampling.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age≥18 years, male or female;
* confirmed acute coronary syndrome patients;
* undergo percutaneous coronary intervention (PCI) treatment;
* agree to participate in this clinical study and sign a written consent form.

Exclusion Criteria

* ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure;
* patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements;
* pregnant women or lactating women;
* investigators consider patients who were not suitable for participation with other reasons
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yun Dai Chen

Director of the Cardiovascular Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yundai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of PLA

Locations

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The General Hospital of PLA

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dandan Li, MD

Role: CONTACT

+8613810545564

Yundai Chen, MD

Role: CONTACT

+8613311119778

Facility Contacts

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Yundai Chen, MD

Role: primary

+8613311119778

Other Identifiers

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CLOPIL08731

Identifier Type: -

Identifier Source: org_study_id

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