Acute Coronary SyndromeNCT03402711
Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II
An observational study of Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Bleeding
- How many people
- 5,500 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2017to Apr 2021
- How long will I take part?
- 12 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients must have been diagnosed as ACS and planned to undergo PCI treatment prior to admission, and the investigators have decided to use antithrombotic therapy.
Who may be able to join
- age≥18 years, male or female;
- confirmed acute coronary syndrome patients;
- undergo percutaneous coronary intervention (PCI) treatment;
- agree to participate in this clinical study and sign a written consent form.
Who cannot join
- ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure;
- patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements;
- pregnant women or lactating women;
- investigators consider patients who were not suitable for participation with other reasons
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The General Hospital of PLA
Beijing, 100853
Yundai Chen, MD, +8613311119778, cyundai@vip.163.com
About this study
The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
Read the detailed description
Acute coronary syndrome (ACS) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation.
With the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for ACS patients after PCI.Moreover,Bleeding after PCI therapy significantly increased short-term and long-term risk of death.
However, there is a lack of data on the risk of bleeding in ACS patients treated with PCI in the clinical reality world of china.
Therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
This study will provide sufficient and reliable evidence for the risk of bleeding and the choice of antithrombotic drugs in ACS patients undergoing PCI in China, and provide a reference for individual antithrombotic therapy after PCI.
- Keywords
- ACS, PCI, Bleeding risk
- Medical subject headings
- Acute Coronary Syndrome, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bleeding Risk in Chinese ACS II | 1.This is an observational study，there is no intervention to be administered. 2.5500 ACS patients who meet the inclusion criteria for PCI treatment will be consecutively enrolled according to random number sampling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of major bleeding during each visit
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard;
Measured: 12 months
Secondary outcomes (1)
the incidence of major adverse cardiovascular events during each visit
Definition of major adverse cardiovascular events（MACE）：Cardiac death, nonfatal myocardial infarction, ischemic stroke, emergency revascularization;
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start14 Dec 2017
- Primary completionApr 2020 (estimated)
- Study completionApr 2021 (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 Chinese PLA General 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, MD, Principal investigator, The General Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402711
- Sponsor's protocol ID
- CLOPIL08731
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II
- ClinicalTrials.gov ID
- NCT03402711
- Acronym / sponsor ID
- CLOPIL08731
- Keywords
- ACS, PCI, Bleeding risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 18 Jan 2018 (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 present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
Detailed description
Acute coronary syndrome (ACS) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation.
With the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for ACS patients after PCI.Moreover,Bleeding after PCI therapy significantly increased short-term and long-term risk of death.
However, there is a lack of data on the risk of bleeding in ACS patients treated with PCI in the clinical reality world of china.
Therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
This study will provide sufficient and reliable evidence for the risk of bleeding and the choice of antithrombotic drugs in ACS patients undergoing PCI in China, and provide a reference for individual antithrombotic therapy after PCI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bleeding Risk in Chinese ACS II | – | –1.This is an observational study，there is no intervention to be administered. 2.5500 ACS patients who meet the inclusion criteria for PCI treatment will be consecutively enrolled according to random number sampling. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients must have been diagnosed as ACS and planned to undergo PCI treatment prior to admission, and the investigators have decided to use antithrombotic therapy.
Key inclusion criteria (4 listed)
- age≥18 years, male or female;
- confirmed acute coronary syndrome patients;
- undergo percutaneous coronary intervention (PCI) treatment;
- agree to participate in this clinical study and sign a written consent form.
Key exclusion criteria (4 listed)
- ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure;
- patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements;
- pregnant women or lactating women;
- investigators consider patients who were not suitable for participation with other reasons
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 incidence of major bleeding during each visit
Time frame: 12 months
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard;
1 secondary outcome
the incidence of major adverse cardiovascular events during each visit
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yundai Chen, MD principal investigator
The General Hospital of PLA
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 and Percutaneous Coronary Intervention, run by Chinese PLA General 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 4 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 Jan 2018. 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 Dandan Li, MD (+8613810545564, ldd301heart@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of major bleeding during each visit (time frame: 12 months). 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 Jan 2018.