Atrial FibrillationACHDAFNCT03051061
Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation
An observational study of Atrial Fibrillation and Coronary Heart Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Heart Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 1 Dec 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coexisting coronary heart disease and atrial fibrillation
Who may be able to join
- Patients with chest pain and a significant lesion >50% angiographically.
- Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.
Who cannot join
- Rheumatic valvular disease.
- Contraindications to oral anticoagulation.
- Combined with other serious diseases with a life expectancy < 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
You Zhang, PhD
About this study
Official title: Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation:A Single-center,Retrospective,Observational Study
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.
Read the detailed description
- 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.
- Conditions
- Atrial Fibrillation, Coronary Heart Disease
- Keywords
- Atrial Fibrillation, Coronary Heart Disease, antithrombotic treatment, clinical prognosis
- Medical subject headings
- Atrial Fibrillation, Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolism
including ischemic stroke and systemic embolization
Measured: 1 year
Secondary outcomes (3)
Hemorrhage
according to GUSTO criteria
Measured: 1 year
Major Adverse Cardiovascular Events(MACE)
death, congestive heart failure, myocardial infarction
Measured: 1 year
A composite outcome
including thromboembolism,hemorrhage,all cause death,congestive heart failure, myocardial infarction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Feb 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changyu Gao, PhD, Principal investigator, Henan Provincial People's HospitalYou Zhang, PhD, Principal investigator, Henan Provincial People's HospitalLili Wei, MD, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051061
- Sponsor's protocol ID
- HenanICE201604
- Acronym
- ACHDAF
- Status last verified
- Mar 2019
- First submitted
- 9 Feb 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation:A Single-center,Retrospective,Observational Study
- ClinicalTrials.gov ID
- NCT03051061
- Acronym / sponsor ID
- ACHDAF / HenanICE201604
- Conditions
- Atrial Fibrillation, Coronary Heart Disease
- Keywords
- Atrial Fibrillation, Coronary Heart Disease, antithrombotic treatment, clinical prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coexisting coronary heart disease and atrial fibrillation
Key inclusion criteria (2 listed)
- Patients with chest pain and a significant lesion >50% angiographically.
- Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.
Key exclusion criteria (3 listed)
- Rheumatic valvular disease.
- Contraindications to oral anticoagulation.
- Combined with other serious diseases with a life expectancy < 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thromboembolism
Time frame: 1 year
including ischemic stroke and systemic embolization
3 secondary outcomes
Hemorrhage
Time frame: 1 year
Major Adverse Cardiovascular Events(MACE)
Time frame: 1 year
A composite outcome
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changyu Gao, PhD principal investigator
Henan Provincial People's Hospital
You Zhang, PhD principal investigator
Henan Provincial People's Hospital
Lili Wei, MD principal investigator
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Coronary Heart Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact You Zhang, PhD (+86 13598019682, 13598019682@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolism (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.