Different β -Blockers in STEMI and Primary PCI

Shandong University

Status: Not yet enrolling

Conditions: Primary PCI

Treatments: Drug: β -Blockers

Study type: Interventional

Funder types: Other

Identifiers

NCT04221919

HR management

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,200 participants in 4 patient groups

Carvedilol

Experimental group

Treatment:

Drug: β -Blockers

Bisoprolol

Experimental group

Treatment:

Drug: β -Blockers

Metoprolol tartrate

Experimental group

Treatment:

Drug: β -Blockers

Metoprolol succinate

Experimental group

Treatment:

Drug: β -Blockers