Different β -Blockers in STEMI and Primary PCI

Primary PCI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04221919
• Other study ID #: HR management
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: January 2025

Study information

• Verified date: January 2020
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: January 2025
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary PCI

Intervention

Drug:
• ß -Blockers
Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Major adverse cardiovascular events (MACE)		1 to 5 years