Different β -Blockers in STEMI and Primary PCI

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

Study Overview

• Status: Not yet recruiting
• Conditions: Primary PCI
• Intervention / Treatment: Drug: β -Blockers

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 Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carvedilol	Drug: β -Blockers; Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate
Experimental: Bisoprolol	Drug: β -Blockers; Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate
Experimental: Metoprolol tartrate	Drug: β -Blockers; Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate
Experimental: Metoprolol succinate	Drug: β -Blockers; Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 to 5 years
Major adverse cardiovascular events (MACE)		1 to 5 years

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Antagonists
• Other Study ID Numbers: HR management

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No