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

Atrial Fibrillation Clinical Trial

— ACHDAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03051061
• Other study ID #: HenanICE201604
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2019
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: You Zhang, PhD
• Phone: +86 13598019682
• Email: 13598019682[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolism	including ischemic stroke and systemic embolization	1 year
Secondary	Hemorrhage	according to GUSTO criteria	1 year
Secondary	Major Adverse Cardiovascular Events(MACE)	death, congestive heart failure, myocardial infarction	1 year
Secondary	A composite outcome	including thromboembolism,hemorrhage,all cause death,congestive heart failure, myocardial infarction	1 year