Clinical trial NCT03051061: Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation
Official title: Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation:A Single-center,Retrospective,Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Coronary Heart Disease
Keywords: Atrial Fibrillation
Coronary Heart Disease
antithrombotic treatment
clinical prognosis
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients with coexisting coronary heart disease and atrial fibrillation

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thromboembolism
timeFrame: 1 year
Secondary outcomes:
measure: Hemorrhage
timeFrame: 1 year
measure: Major Adverse Cardiovascular Events(MACE)
timeFrame: 1 year
measure: A composite outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Changyu Gao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: You Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Lili Wei, MD
role: PRINCIPAL_INVESTIGATOR
References: