Different β -Blockers in STEMI and Primary PCI

NCT ID: NCT04221919

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2025-01-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Carvedilol

Group Type: EXPERIMENTAL

β -Blockers

Intervention Type: DRUG

Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

Bisoprolol

Group Type: EXPERIMENTAL

β -Blockers

Intervention Type: DRUG

Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

Metoprolol tartrate

Group Type: EXPERIMENTAL

β -Blockers

Intervention Type: DRUG

Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

Metoprolol succinate

Group Type: EXPERIMENTAL

β -Blockers

Intervention Type: DRUG

Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

Interventions

β -Blockers

Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Pan-Pan Hao

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HR management

Identifier Type: -

Identifier Source: org_study_id