Drug TherapyNCT04184583
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome
An observational study of Drug Therapy and Acute Coronary Syndrome, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Therapy, Acute Coronary Syndrome
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2019to Dec 2026
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Acute Coronary Syndrome with blood concentration monitoring or genetic testing at the pharmacy department of Beijing Anzhen Hospital from January 1, 2018.Those who fill the inclusion criteria at screening will be invited for the registry study into different groups.
Who may be able to join
- Informed consent has been signed.
- Patients diagnosed in our hospital with acute coronary syndrome.
- Age ≥18.
- Life expectancy ≥12 months.
Who cannot join
- Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
- Pregnant and lactating women.
- Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yang Lin, PhD, 86-010-64456609, linyang3623@outlook.com
Xiujing Shi, MD, 86-010-64456609, xiujingshi@163.com
About this study
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome
- Conditions
- Drug Therapy, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
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 5 years
Secondary outcomes (1)
Adverse drug reaction
Adverse drug reaction will be defined as any adverse reactions in the patients.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug TherapyStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 6 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
- NCT04184583
- Sponsor's protocol ID
- ANZHEN HOSPITOL-LY-02
- Status last verified
- Nov 2019
- First submitted
- 28 Nov 2019
- Last updated
- 3 Dec 2019
- 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 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04184583
- Acronym / sponsor ID
- ANZHEN HOSPITOL-LY-02
- Conditions
- Drug Therapy, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Dec 2019 (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.
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Acute Coronary Syndrome with blood concentration monitoring or genetic testing at the pharmacy department of Beijing Anzhen Hospital from January 1, 2018.Those who fill the inclusion criteria at screening will be invited for the registry study into different groups.
Key inclusion criteria (4 listed)
- Informed consent has been signed.
- Patients diagnosed in our hospital with acute coronary syndrome.
- Age ≥18.
- Life expectancy ≥12 months.
Key exclusion criteria (3 listed)
- Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
- Pregnant and lactating women.
- 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 5 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 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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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.
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 Drug Therapy and Acute Coronary Syndrome, run by Beijing Anzhen Hospital 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 4 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: opening soon, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang, PhD (86-010-64456609, phd-zhangyi@outlook.com), 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 5 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 3 Dec 2019.