Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome

November 29, 2019 updated by: Lin Yang, Beijing Anzhen Hospital
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Acute Coronary Syndrome with blood concentration monitoring or genetic testing at the pharmacy department of Beijing Anzhen Hospital from January 1, 2018.Those who fill the inclusion criteria at screening will be invited for the registry study into different groups.

Description

Inclusion Criteria:

  • Informed consent has been signed.
  • Patients diagnosed in our hospital with acute coronary syndrome.
  • Age ≥18.
  • Life expectancy ≥12 months.

Exclusion Criteria:

  • Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
  • Pregnant and lactating women.
  • Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
main adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: up to 5 years
MACCE will be defined as all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug reaction
Time Frame: up to 5 years
Adverse drug reaction will be defined as any adverse reactions in the patients.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2026

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (ACTUAL)

December 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 29, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZHEN HOSPITOL-LY-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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