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Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation

Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation:A Single-center,Retrospective,Observational Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03051061
Acronym
ACHDAF
Enrollment
1000
Registered
2017-02-13
Start date
2017-02-01
Completion date
2019-12-01
Last updated
2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Coronary Heart Disease

Keywords

Atrial Fibrillation, Coronary Heart Disease, antithrombotic treatment, clinical prognosis

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.

Detailed description

1. Our study is an observational, retrospective Study. 2. Key date elements and definition of each variable were in line with the American Heart Association(AHA)/European Society of Cardiology(ECS) recommendation on AF and CHD. To reflect the contemporary antithrombotic management of AF and CHD in the past five years, the following data were collected: basic socio-demographic information, symptoms and signs relating to AF, medical history, results of physical examination and laboratory test. 3. Follow-up time is at least 12 months. The patients will be asked about their medications and clinical outcomes by telephone interview or outpatient clinic. Then we will analyze the relative safety and efficacy of the various antithrombotic regimens. 4. Based on the largest prospective study by Denmark about this issue, we anticipate an 30% incidence of composite outcome in the triple therapy arm. To achieve a precision of 10% with an α=0.05 and the rate of defaulters is 10%. The final estimated sample size was 986. 5. Henan institute of cardiology epidemiology is responsible for design, date quality control and statistical analysis.

Interventions

None listed

Sponsors

Henan Institute of Cardiovascular Epidemiology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients with chest pain and a significant lesion \>50% angiographically. 2. Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.

Exclusion criteria

1. Rheumatic valvular disease. 2. Contraindications to oral anticoagulation. 3. Combined with other serious diseases with a life expectancy \< 1 year.

Design outcomes

Primary

MeasureTime frameDescription
Thromboembolism1 yearincluding ischemic stroke and systemic embolization

Secondary

MeasureTime frameDescription
Major Adverse Cardiovascular Events(MACE)1 yeardeath, congestive heart failure, myocardial infarction
Hemorrhage1 yearaccording to GUSTO criteria
A composite outcome1 yearincluding thromboembolism,hemorrhage,all cause death,congestive heart failure, myocardial infarction

Countries

China

Contacts

Primary ContactYou Zhang, PhD
13598019682@126.com+86 13598019682
Backup ContactChangyu Gao, PhD
gaocy6802@163.com+86 13937165590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026