NCT03051061

Brief Summary

The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with Atrial Fibrillation (AF) is unresolved at present. Although the European and American guidelines have given a hand for us, there is absence of real-world data on the safety and efficacy of antithrombotic therapy in Asian populations. Only a few clinical trials are available to guide difficult decision on antithrombotic therapy in patients with combined AF and CHD,the investigators highlight the need for the rapid development of clinical trials to close the large gaps in evidence. This research aims to know the real-world use of antithrombotic treatment and clinical prognosis in Coronary Heart Disease patients complicated with Atrial Fibrillation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

February 9, 2017

Last Update Submit

December 11, 2019

Conditions

Keywords

Atrial FibrillationCoronary Heart Diseaseantithrombotic treatmentclinical prognosis

Outcome Measures

Primary Outcomes (1)

  • Thromboembolism

    including ischemic stroke and systemic embolization

    1 year

Secondary Outcomes (3)

  • Hemorrhage

    1 year

  • Major Adverse Cardiovascular Events(MACE)

    1 year

  • A composite outcome

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with coexisting coronary heart disease and atrial fibrillation

You may qualify if:

  • Patients with chest pain and a significant lesion \>50% angiographically.
  • Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.

You may not qualify if:

  • Rheumatic valvular disease.
  • Contraindications to oral anticoagulation.
  • Combined with other serious diseases with a life expectancy \< 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationCoronary Disease

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaVascular Diseases

Study Officials

  • Changyu Gao, PhD

    Henan Provincial People's Hospital

    PRINCIPAL INVESTIGATOR
  • You Zhang, PhD

    Henan Provincial People's Hospital

    PRINCIPAL INVESTIGATOR
  • Lili Wei, MD

    Henan Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changyu Gao, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

February 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations