Metoprolol to Reduce Perioperative Myocardial Injury

NCT03138603 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: IRB19-17975R01HL126892
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to test if a commonly used, FDA-approved medication, called metoprolol, given at the conclusion of anesthesia following surgery, and during postoperative admission, reduces the possibility of heart related complications in patients with coronary artery disease (CAD).

Conditions

Heart Diseases

Keywords

surgery; heart disease; metoprolol; myocardial injury; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury

  Measured effectiveness of post-operative beta-blocker therapy to reduce myocardial injury by monitoring daily biomarkers (High-Sensitivity cardiac Troponin \[HS-cTn\]). Daily post-operative biomarker (hs-cTn) measurements to determine myocardial injury. Myocardial injury is defined as a new hscTn elevation \>99th percentile, or a 50% increase if the baseline hscTn is already elevated \>99th percentile

  0-3 days, following surgery

Secondary Outcomes (8)

• Effectiveness in Reduction of Major Adverse Cardiac Events (MACE)

  0-3 days, following surgery

• Monitor Post-operative Myocardial Ischemia

  0-3 days, following surgery

• Number of Stroke Related Events Following Surgery

  0-3 days, following surgery

• Number of Participants Having Vasopressor Therapy to Regulate Symptomatic Hypotension

  0-3 days, following surgery

• Number of Participant Incidence of Clinically Relevant Bradycardia

  0-3 days, following surgery

Other Outcomes (1)

• Measured Number of Patient Adverse Events

  Post-operatively, 0-3 days, and day-30

Study Arms (2)

Metoprolol

EXPERIMENTAL

Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).

Drug: Metoprolol Tartrate

Placebo

PLACEBO COMPARATOR

Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).

Drug: Placebo

Interventions

Metoprolol Tartrate DRUG

Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).

Also known as: Beta-blocker

Metoprolol

Placebo DRUG

Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).

Also known as: Sham, Placebo-comparator, Control

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 50 years
• Beta-blocker naïve \[30 days prior to surgery\]
• Previously diagnosed coronary artery disease (CAD), or
• History of peripheral vascular disease (PVD), or
• Chronic kidney disease (CKD) \[eGFR ≤60ml/min\], or
• History of positive stress test or
• At high risk for CAD (must meet at least 2 criteria):
• i. Age \>= 70 years ii. Hypertension iii. Diabetes requiring oral medication or insulin iv. Current smoker or some days smoker within the past 2 years
• Major non-cardiac, elective surgery under general anesthesia

You may not qualify if:

• Subjects will not be enrolled if any of the following criteria exist:
• History of stroke, or transient ischemic attack (TIA)
• Previously diagnosed carotid disease, i.e., either 70% unilateral or 50% bilateral carotid occlusion.
• Heart rate \<=55bpm
• Congestive heart failure with New York Heart Association(NYHA) Functional Classification of III-IV or left ventricular heart failure with ejection fraction ≤50%
• Severe valvular regurgitation
• Second or third degree atrioventricular (AV) block without pacemaker
• Active asthma or chronic obstructive pulmonary disease (COPD) with symptoms or resolving symptoms on day of surgery
• Anemia \[HB\<=9g/dL\]
• Allergy to beta-blockade drugs
• Unwilling or unable to give consent for participation
• Undergoing any carotid endarterectomy, endovascular, endoscopic, superficial, or ambulatory procedures
• Pregnancy or lactating women
• Prisoners

Sponsors & Collaborators

• University of Chicago: lead
• Washington University School of Medicine: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease

Interventions

Metoprolol; Adrenergic beta-Antagonists; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Results Point of Contact

• Title: Peter Nagele, MD, MSc
• Organization: University of Chicago Medicine

pnagele@uchicagomedicine.org

773-795-3544

Study Officials

• Peter Nagele, MD

  University of Chicago Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, double blinded placebo controlled

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 3, 2017
• Study Start: December 1, 2016
• Primary Completion: April 18, 2023
• Study Completion: August 29, 2023
• Last Updated: January 28, 2026
• Results First Posted: February 5, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)