Actue Coronary SyndromeNCT03658577
Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With Actue Coronary Syndrome
An observational study of Actue Coronary Syndrome, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Limited data are available on the efficacy of beta-blocker therapy for secondary prevention in Actue Coronary Syndrome(ACS) patients. This study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ACS after percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actue Coronary Syndrome
- How many people
- 582 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2018to Dec 2023
- 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: The study population was selected from ten major cardiac centres in ShenZhen,CHINA.
Who may be able to join
- consecutive patients 18 years of age or older;
- patients diagnosed as ACS(including STEMI、NSTEMI and UA) by doctor at discharge;
- patients undergoing primary PCI.
Who cannot join
- missing beta-blocker information.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
ShaoHong Dong, PhD, +8613509633742, dsh266@outlook.com
Feng Lin, MD, +8613510730251, 119538892@qq.com
About this study
Official title: Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With Actue Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Limited data are available on the efficacy of beta-blocker therapy for secondary prevention in Actue Coronary Syndrome(ACS) patients. This study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ACS after percutaneous coronary intervention (PCI).
Read the detailed description
The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommend beta-blockers for secondary prevention in patients with ACS without regard to reperfusion therapy. However, evidence supporting this recommendation originated from studies conducted before the introduction of reperfusion therapy or studies in patients treated with fibrinolysis. In the present era of PCI, there are no prospective randomized studies looking at the effects of long-term beta-blocker therapy on clinical outcomes in ACS patients. Moreover, results from registry data and post-hoc analysis on beta-blocker therapy in patients undergoing PCI are inconsistent.
In particular, the beneficial effect of long-term beta-blocker therapy has not been well established in patients with relatively low risk, such as preserved left ventricular systolic function or single-vessel disease. Therefore, we investigated the association of beta-blocker therapy at discharge with clinical outcomes in ACS patients after PCI.
- Conditions
- Actue Coronary Syndrome
- Keywords
- Actue Coronary Syndrome, Beta-Blocker, Percutaneous Coronary Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
The primary outcome was all-cause death during follow up.
Measured: 3 years
Secondary outcomes (1)
MACE
Secondary outcomes included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, stroke, any revascularization during follow-up
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start2 Mar 2018
- Primary completionAug 2019 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actue Coronary SyndromeStudies 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
- Prospective
- Enrolment
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ShaoHong P Dong, PhD, Principal investigator, professor, Chief of cardiovascular department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658577
- Sponsor's protocol ID
- COE20180821
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With Actue Coronary Syndrome Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03658577
- Acronym / sponsor ID
- COE20180821
- Conditions
- Actue Coronary Syndrome
- Keywords
- Actue Coronary Syndrome, Beta-Blocker, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Sep 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.
Limited data are available on the efficacy of beta-blocker therapy for secondary prevention in Actue Coronary Syndrome(ACS) patients. This study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ACS after percutaneous coronary intervention (PCI).
Detailed description
The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommend beta-blockers for secondary prevention in patients with ACS without regard to reperfusion therapy. However, evidence supporting this recommendation originated from studies conducted before the introduction of reperfusion therapy or studies in patients treated with fibrinolysis. In the present era of PCI, there are no prospective randomized studies looking at the effects of long-term beta-blocker therapy on clinical outcomes in ACS patients. Moreover, results from registry data and post-hoc analysis on beta-blocker therapy in patients undergoing PCI are inconsistent.
In particular, the beneficial effect of long-term beta-blocker therapy has not been well established in patients with relatively low risk, such as preserved left ventricular systolic function or single-vessel disease. Therefore, we investigated the association of beta-blocker therapy at discharge with clinical outcomes in ACS patients after PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was selected from ten major cardiac centres in ShenZhen,CHINA.
Key inclusion criteria (3 listed)
- consecutive patients 18 years of age or older;
- patients diagnosed as ACS(including STEMI、NSTEMI and UA) by doctor at discharge;
- patients undergoing primary PCI.
Key exclusion criteria (1 listed)
- missing beta-blocker information.
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
all-cause death
Time frame: 3 years
The primary outcome was all-cause death during follow up.
1 secondary outcome
MACE
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Actue Coronary Syndrome
Not yet recruitingObservational study
Clinical Features and Linked mEchanisms in Acute Risk-free AMI
Actue Coronary Syndrome
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.
ShaoHong P Dong, PhD principal investigator
professor, Chief of cardiovascular department
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 Actue Coronary Syndrome, run by Shenzhen People's 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 1 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 5 Sep 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 Feng Lin, MD (+8613510730251, 119538892@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death (time frame: 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 5 Sep 2018.