NCT04184583

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Dec 2019Dec 2026

First Submitted

Initial submission to the registry

November 28, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

6 years

First QC Date

November 28, 2019

Last Update Submit

November 29, 2019

Conditions

Drug TherapyAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • main adverse cardiovascular and cerebrovascular events (MACCE)

    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 Outcomes (1)

  • Adverse drug reaction

    up to 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Part of DNA samples were preserved in the -80℃.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Yi Zhang, PhD

CONTACT

86-010-64456609phd-zhangyi@outlook.com

Yang Lin, PhD

CONTACT

86-010-64456609linyang3623@outlook.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of pharmacy department of Beijing Anzhen Hospital

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 3, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

December 3, 2019

Record last verified: 2019-11

Locations

CN(1)