Primary PCINCT04221919

Different β -Blockers in STEMI and Primary PCI

A study testing β -Blockers in people with Primary PCI, run by Qilu Hospital of Shandong University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary PCI
What is being tested?: β -Blockers
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,200 participants
Where: No sites listed yet
Study dates: Jan 2020to Jan 2025
Phase: Interventional
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

Who may be able to join

Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
Age ≥18 years;
Informed consent from patient or next of kin.

Who cannot join

Nonischaemic Cardiomyopathy;
Cardiac surgery planed in the 6 months;
Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
Renal or hepatic failure;
Malignancy, HIV, or central nervous system disorder;
Cardiopulmonary resuscitation >15 min and compromised level of consciousness;

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Cardiogenic shock;
Current participation in any research study involving investigational drugs or devices;
No written consensus;
Previous myocardial infarction.

About this study

Official title: Different β -Blockers in Patients With ST-segment Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily

Read the detailed description

The investigators will investigate the efficacy and safety of different β -blockers, as well as heart rate variability, in STEMI patients undergoing primary PCI.

Conditions: Primary PCI
Being tested: β -Blockers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

β -BlockersDrug
Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

Study groups in NCT04221919
Study group	Role	What they receive
Carvedilol	Experimental	Not described Receives: Drug: β -Blockers
Bisoprolol	Experimental	Not described Receives: Drug: β -Blockers
Metoprolol tartrate	Experimental	Not described Receives: Drug: β -Blockers
Metoprolol succinate	Experimental	Not described Receives: Drug: β -Blockers

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in LVEDV from baseline
The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) post-PCI.
Measured: 1 to 5 years
Major adverse cardiovascular events (MACE)
Measured: 1 to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2020Jan 2025

First posted9 Jan 2020
Study startJan 2020 (estimated)
Primary completionJan 2021 (estimated)
Study completionJan 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary PCIStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 1,200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04221919
Sponsor's protocol ID: HR management
Status last verified: Jan 2020
First submitted: 5 Jan 2020
Last updated: 9 Jan 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
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RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
Not yet recruitingPhase 4
IMPROVE-STEMI: pPCI Plus Low-dose r-SK in STEMI
ST Elevation Myocardial Infarction (STEMI)
Not yet recruitingObservational study
Multimodality Assessment of Myocardial Reperfusion After Primary Percutaneous Coronary Intervention
ST Elevation (STEMI) Myocardial Infarction, Microvascular Obstruction (MVO)
Active, not recruitingObservational study
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
Coronary Disease

All Primary PCI trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Different β -Blockers in Patients With ST-segment Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT04221919
Acronym / sponsor ID: HR management
Conditions: Primary PCI
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,200 participants (estimated)
Lead sponsor: Qilu Hospital of Shandong UniversityUniversity, hospital or other
Study start: Jan 2020 (estimated)
Primary completion: Jan 2021 (estimated)
Study completion: Jan 2025 (estimated)
First posted: 9 Jan 2020 (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.

Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily

Detailed description

The investigators will investigate the efficacy and safety of different β -blockers, as well as heart rate variability, in STEMI patients undergoing primary PCI.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Carvedilol	Experimental	Drug: β -Blockers
Bisoprolol	Experimental	Drug: β -Blockers
Metoprolol tartrate	Experimental	Drug: β -Blockers
Metoprolol succinate	Experimental	Drug: β -Blockers

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
Age ≥18 years;
Informed consent from patient or next of kin.

Key exclusion criteria (10 listed)

Nonischaemic Cardiomyopathy;
Cardiac surgery planed in the 6 months;
Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
Renal or hepatic failure;
Malignancy, HIV, or central nervous system disorder;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
β -BlockersTarget doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate	Drug	Bisoprolol, Carvedilol, Metoprolol succinate, Metoprolol tartrate

Primary outcome

Change in LVEDV from baseline
Time frame: 1 to 5 years
The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) post-PCI.
Major adverse cardiovascular events (MACE)
Time frame: 1 to 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.

Related trials for Primary PCI

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
Not yet recruitingPhase 4
IMPROVE-STEMI: pPCI Plus Low-dose r-SK in STEMI
ST Elevation Myocardial Infarction (STEMI)
Not yet recruitingObservational study
Multimodality Assessment of Myocardial Reperfusion After Primary Percutaneous Coronary Intervention
ST Elevation (STEMI) Myocardial Infarction, Microvascular Obstruction (MVO)
Active, not recruitingObservational study
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
Coronary Disease

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.

Questions about this trial

What is this clinical trial studying?

A study testing β -Blockers in people with Primary PCI, run by Qilu Hospital of Shandong University.

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 10 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 9 Jan 2020. 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?

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?

Change in LVEDV from baseline (time frame: 1 to 5 years). 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?

On the ClinicalTrials.gov record for NCT04221919.

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 9 Jan 2020.