Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation
NCT ID: NCT03051061
Last Updated: 2019-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2017-02-01
2019-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
2. Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.
Exclusion Criteria
2. Contraindications to oral anticoagulation.
3. Combined with other serious diseases with a life expectancy \< 1 year.
18 Years
ALL
No
Sponsors
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Henan Institute of Cardiovascular Epidemiology
OTHER
Responsible Party
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Principal Investigators
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Changyu Gao, PhD
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
You Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Lili Wei, MD
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Locations
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Henan Provincial People's Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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You Zhang, PhD
Role: primary
Other Identifiers
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HenanICE201604
Identifier Type: -
Identifier Source: org_study_id