Acute Coronary SyndromeNCT04162808
Bleeding Risk Assessment System for Antithrombotic Therapy of ACS
An observational study of Acute Coronary Syndrome, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 6,379 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2018to 31 Dec 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACS patients
Who may be able to join
- Age18-85 years old
- Diagnosed ACS
- Signed informed consent form
Who cannot join
- Any active bleeding
- Not tolerate to anti-thrombotic drugs
- A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment
- Patients who died of non-bleeding causes within 24 hours after admission
- Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome
Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.
- Conditions
- Acute Coronary Syndrome
- Keywords
- bleeding, antithrombosis
- Medical subject headings
- Acute Coronary Syndrome, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of event of bleeding
The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment
Measured: 30 days
The number of event of bleeding
The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment
Measured: 1 year
Secondary outcomes (2)
The number of event of bleeding
The number of event of bleeding (BARC 1 to 5) within 30 days and 1year after enrollment
Measured: 30 days and 1 year
number of event of major adverse cardiovascular or cerebrovascular events
number of event of major adverse cardiovascular or cerebrovascular events within 30 days and 1year after enrollment
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start4 Jan 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Prospective
- Enrolment
- 6,379 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Hospital, Beijing Luhe Hospital, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162808
- Sponsor's protocol ID
- 2018055X
- Status last verified
- Apr 2022
- First submitted
- 12 Nov 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04162808
- Acronym / sponsor ID
- 2018055X
- Conditions
- Acute Coronary Syndrome
- Keywords
- bleeding, antithrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,379 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Hospital, Beijing Luhe Hospital, Beijing Chao Yang Hospital
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Nov 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.
Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACS patients
Key inclusion criteria (3 listed)
- Age18-85 years old
- Diagnosed ACS
- Signed informed consent form
Key exclusion criteria (6 listed)
- Any active bleeding
- Not tolerate to anti-thrombotic drugs
- A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment
- Patients who died of non-bleeding causes within 24 hours after admission
- Noncardiac coexisting conditions that could limit life expectancy to less than 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
The number of event of bleeding
Time frame: 30 days
The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment
The number of event of bleeding
Time frame: 1 year
The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment
2 secondary outcomes
The number of event of bleeding
Time frame: 30 days and 1 year
number of event of major adverse cardiovascular or cerebrovascular events
Time frame: 30 days and 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 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 3 inclusion and 6 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 Apr 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of event of bleeding (time frame: 30 days). The study lists 2 primary outcomes in all. 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 Apr 2022.