Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation (ACHDAF)
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|ClinicalTrials.gov Identifier: NCT03051061|
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : December 12, 2019
|Condition or disease|
|Atrial Fibrillation Coronary Heart Disease|
- Our study is an observational, retrospective Study.
- 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.
- 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.
- 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.
- Henan institute of cardiology epidemiology is responsible for design, date quality control and statistical analysis.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation:A Single-center,Retrospective,Observational Study|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
- Thromboembolism [ Time Frame: 1 year ]including ischemic stroke and systemic embolization
- Hemorrhage [ Time Frame: 1 year ]according to GUSTO criteria
- Major Adverse Cardiovascular Events(MACE) [ Time Frame: 1 year ]death, congestive heart failure, myocardial infarction
- A composite outcome [ Time Frame: 1 year ]including thromboembolism,hemorrhage,all cause death,congestive heart failure, myocardial infarction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051061
|Contact: You Zhang, PhD||+86 firstname.lastname@example.org|
|Contact: Changyu Gao, PhD||+86 email@example.com|
|Henan Provincial People's Hospital||Recruiting|
|Zhengzhou, Henan, China, 450000|
|Contact: You Zhang, PhD|
|Principal Investigator:||Changyu Gao, PhD||Henan Province People's Hospital|
|Principal Investigator:||You Zhang, PhD||Henan Province People's Hospital|
|Principal Investigator:||Lili Wei, MD||Henan Province People's Hospital|