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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
Sponsor:
Information provided by (Responsible Party):
Henan Institute of Cardiovascular Epidemiology

Study Description
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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.

Condition or disease
Atrial Fibrillation Coronary Heart Disease

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Thromboembolism [ Time Frame: 1 year ]
    including ischemic stroke and systemic embolization


Secondary Outcome Measures :
  1. Hemorrhage [ Time Frame: 1 year ]
    according to GUSTO criteria

  2. Major Adverse Cardiovascular Events(MACE) [ Time Frame: 1 year ]
    death, congestive heart failure, myocardial infarction

  3. A composite outcome [ Time Frame: 1 year ]
    including thromboembolism,hemorrhage,all cause death,congestive heart failure, myocardial infarction


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with coexisting coronary heart disease and atrial fibrillation
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: You Zhang, PhD +86 13598019682 13598019682@126.com
Contact: Changyu Gao, PhD +86 13937165590 gaocy6802@163.com

Locations
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China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: You Zhang, PhD         
Sponsors and Collaborators
Henan Institute of Cardiovascular Epidemiology
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Henan Institute of Cardiovascular Epidemiology
ClinicalTrials.gov Identifier: NCT03051061    
Other Study ID Numbers: HenanICE201604
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Henan Institute of Cardiovascular Epidemiology:
Atrial Fibrillation
Coronary Heart Disease
antithrombotic treatment
clinical prognosis
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arrhythmias, Cardiac
 Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases