Trial Outcomes & Findings for Metoprolol to Reduce Perioperative Myocardial Injury (NCT NCT03138603)
NCT ID: NCT03138603
Last Updated: 2026-01-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
0-3 days, following surgery
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Metoprolol
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).
Metoprolol Tartrate: 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).
|
Placebo
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).
Placebo: 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).
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
38
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metoprolol to Reduce Perioperative Myocardial Injury
Baseline characteristics by cohort
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
|
Placebo
n=38 Participants
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).
Placebo: 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).
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
10 Participants
n=315 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=158 Participants
|
32 Participants
n=157 Participants
|
62 Participants
n=315 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=158 Participants
|
19 Participants
n=157 Participants
|
43 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=158 Participants
|
19 Participants
n=157 Participants
|
29 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=158 Participants
|
38 Participants
n=157 Participants
|
71 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
12 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=158 Participants
|
30 Participants
n=157 Participants
|
56 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=158 Participants
|
38 participants
n=157 Participants
|
72 participants
n=315 Participants
|
PRIMARY outcome
Timeframe: 0-3 days, following surgeryPopulation: Analysis is comprised of participants meeting criteria for randomization to receive intervention, with biomarker (hs-cTn) showing increased value(s).
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
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury
|
9 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 0-3 days, following surgeryPopulation: MACE analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, having myocardial ischemia, cardiac death, or coronary revascularization.
MACE are defined as myocardial ischemia (MI), cardiac death or coronary revascularization
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Effectiveness in Reduction of Major Adverse Cardiac Events (MACE)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-3 days, following surgeryPopulation: Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative cardiac monitoring (ECG), showing myocardial ischemia is present. Myocardial Ischemia is defined as ST depression or elevation of ≥0.2 mV in one lead or ≥0.1 mV in two contiguous leads lasting ≥10 min
Post-operative cardiac monitoring via ECG to evaluate if myocardial ischemia is present. Myocardial Ischemia is defined as ST depression or elevation of ≥0.2 mV in one lead or ≥0.1 mV in two contiguous leads lasting ≥10 min
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Monitor Post-operative Myocardial Ischemia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-3 days, following surgeryPopulation: Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative sudden onset of neurological effects from cerebral dysfunction.
Stroke will be defined as focal or global cerebral, spinal, or retinal dysfunction of sudden onset
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Number of Stroke Related Events Following Surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-3 days, following surgeryPopulation: Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, having significant post-operative hypotension (systolic BP \< 90 mmHg), requiring therapeutic intervention (vasopressor).
Monitor participants with vasopressor requirements for blood pressure regulation due to symptomatic hypotension (rate/duration time). Symptomatic hypotension (systolic BP \< 90 mmHg) can be determined by clinical intervention due to low blood pressure and/or patient developed clinical symptoms due to hypotension.
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Number of Participants Having Vasopressor Therapy to Regulate Symptomatic Hypotension
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-3 days, following surgeryMonitored participants with cumulative events of bradycardia (rate/duration time). Bradycardia is defined as low heart rate (HR \< 50/min).
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Number of Participant Incidence of Clinically Relevant Bradycardia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0-3 days following surgeryPopulation: Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative length of hospital stay in days.
Measurement of participants number of days spent hospitalized (0-3 days) following surgery.
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Participants Number of Days Spent Post-operative Hospitalization
Participant post-operative Intensive Care Unit (ICU) hospitalization in days
|
2 days
Interval 2.0 to 3.0
|
3 days
Interval 2.0 to 3.0
|
|
Participants Number of Days Spent Post-operative Hospitalization
Participant post-operative hospitalization in days
|
2.5 days
Interval 2.0 to 3.0
|
2.5 days
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: 30-days from surgeryPopulation: Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, with post-operative 1-month follow up showing readmission since surgical discharge.
Measured number of participant post-operative recovery events, 30-days following the surgical procedure.
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Patient Recovery Progress Events at 30-days Post-operative.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-Year from surgeryPopulation: Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, deceased within 1-year of post-operative discharge.
Measured number of patient post-operative mortality at 1-year. Measured by 'living', 'deceased', 'date of death'.
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Participant Post-operative Mortality at 1-year Following Surgery
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-operatively, 0-3 days, and day-30Population: Analysis is comprised of eligible participants meeting criteria for randomization to receive intervention, having post-operative adverse events.
Number of measured participant adverse events and severity associated with low blood pressure (hypotension), low heart heart (bradycardia), nausea and vomiting; or other symptoms determined 'probably', 'possibly', 'unrelated', or 'related' to the study intervention. This includes any unplanned escalation of care admissions (e.g., Intensive Care Unit \[ICU\]). Study patient safety is monitored by the investigators (MD) with experience in critical care anesthesia, as well as an experienced clinical research team responsible for data collection and reporting of events.
Outcome measures
| Measure |
Metoprolol
n=34 Participants
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 Participants
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Measured Number of Patient Adverse Events
Hypotension
|
7 Participants
|
2 Participants
|
|
Measured Number of Patient Adverse Events
Bradycardia
|
0 Participants
|
1 Participants
|
|
Measured Number of Patient Adverse Events
Death
|
0 Participants
|
0 Participants
|
|
Measured Number of Patient Adverse Events
Cardiac Arrest
|
0 Participants
|
0 Participants
|
Adverse Events
Metoprolol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metoprolol
n=34 participants at risk
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 participants at risk
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Cardiac disorders
MACE events
|
0.00%
0/34 • Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.
|
0.00%
0/38 • Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.
|
Other adverse events
| Measure |
Metoprolol
n=34 participants at risk
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).
Metoprolol Tartrate: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group.
|
Placebo
n=38 participants at risk
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).
Placebo: 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).
Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group.
|
|---|---|---|
|
Cardiac disorders
Bradycardia Event
|
0.00%
0/34 • Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.
|
|
Cardiac disorders
Hypotension event
|
23.5%
8/34 • Number of events 8 • Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.
|
5.3%
2/38 • Number of events 2 • Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place