Elderly PatientsNCT05246722
Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease (PHARM-ageing)
An observational study of Elderly Patients and Coronary Heart Disease, run by Beijing Anzhen Hospital.
Trial summary
A registry study on drug therapy and clinical outcomes in elderly patients with coronary heart disease Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patients, Coronary Heart Disease, Drug Therapy
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Dec 2025
- How long will I take part?
- 3 Years
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (≥65 years) with coronary heart disease who discharged at Beijing Anzhen Hospital from January 1, 2019.Those who fill the inclusion criteria at screening will be invited for the registry study.
Who may be able to join
- Informed consent has been signed
- Patients diagnosed in our hospital with coronary heart disease
- Age ≥65 years
Who cannot join
- Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
- Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease
A registry study on drug therapy and clinical outcomes in elderly patients with coronary heart disease
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
main adverse cardiovascular and cerebrovascular events (MACCE)
MACCE will be defined as all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization
Measured: up to 3 years
Secondary outcomes (1)
Adverse drug reaction
Adverse drug reaction will be defined as any adverse reactions in the patients
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- 15,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246722
- Sponsor's protocol ID
- ANZHEN HOSPITOL-LY-03
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT05246722
- Acronym / sponsor ID
- ANZHEN HOSPITOL-LY-03
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Feb 2022 (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.
A registry study on drug therapy and clinical outcomes in elderly patients with coronary heart disease
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (≥65 years) with coronary heart disease who discharged at Beijing Anzhen Hospital from January 1, 2019.Those who fill the inclusion criteria at screening will be invited for the registry study.
Key inclusion criteria (3 listed)
- Informed consent has been signed
- Patients diagnosed in our hospital with coronary heart disease
- Age ≥65 years
Key exclusion criteria (2 listed)
- Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
- Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.
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
main adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: up to 3 years
MACCE will be defined as all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization
1 secondary outcome
Adverse drug reaction
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Patients and Coronary Heart Disease, run by Beijing Anzhen Hospital.
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 3 inclusion and 2 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Yunnan Zhang, PhD (86-010-64456609, zhangyn125@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
main adverse cardiovascular and cerebrovascular events (MACCE) (time frame: up to 3 years). 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 18 Feb 2022.