Clinical Trial Results:
Use of Esmolol for Tight Heart Rate Control for 24 Hours in Patients with Acute ST Elevation Myocardial Infarction: The BEtA-Blocker Therapy in Acute Myocardial Infarction (BEAT-AMI) Trial
Study Title: Herzfrequenzkontrolle nach akutem Myokardinfarkt ("Heart rate control after acute myocardial infarct")
Study Short Title: STEMI
Summary
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EudraCT number |
2011-000911-26 |
Trial protocol |
DE |
Global end of trial date |
24 Feb 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Sep 2021
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First version publication date |
18 Sep 2021
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Other versions |
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Summary report(s) |
STEMI_Summary_report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Uni-Koeln-1392
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
DRKS number: DKRS00000766 | ||
Sponsors
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Sponsor organisation name |
University of Cologne
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Sponsor organisation address |
Albertus-Magnus-Platz, Cologne, Germany, 50923
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Public contact |
Priv.-Doz. Dr. Er, Klinikum Guetersloh, Department of Internal Medicine 1, +49 54218324402, Fikret.Er@klinikum-guetersloh.de
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Scientific contact |
Priv.-Doz. Dr. Er, Klinikum Guetersloh, Department of Internal Medicine 1, +49 54218324402, Fikret.Er@klinikum-guetersloh.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Feb 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Feb 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Feb 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy and safety of esmolol-induced heart rate control
as compared with placebo when used in addition to standard medical
therapy in patients with acute ST elevation myocardial infarction
(STEMI) in reducing final infarct size reflected by Troponin T release.
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Protection of trial subjects |
The trial was conducted according to Good Clinical Practice guidelines, the applicable local laws, and in
accordance with the ethical principles that have their origins in the Declaration of Helsinki.
The competent authorities approved the trial as required by national regulations.
Regulatory authorities were notified of the trial and amendments as required by national regulations.
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Background therapy |
After successful percutaneous coronary intervention (PCI) all patients are getting treated in line with current national and international cardiology Guidelines. This Treatment usually consists of an ACE inhibitor, an oral beta blocker, Aspirin, an ADP receptor antagonist, a statine as well as unfractioned heparin. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Oct 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
50
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From 65 to 84 years |
50
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85 years and over |
0
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Recruitment
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Recruitment details |
Date of first enrollment (FPFV): 13.10.2011 Date of last completed (LPLV): 24.02.2014 | |||||||||
Pre-assignment
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Screening details |
Patients admitted with acute ST elevation myocardial infarction were screened. Subjects underwent timely successful percutaneous intervention were identified. Eligible subjects were included and randomly allocated to receive esmolol or placebo for 24 Hours. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
Because study drug esmolol has an obvious effect on heart rate and blood pressure and due to safety reasons drug-administrating physician was not blinded. Follow up data acquisition was strictly performed in a blinded manner of physician and patient.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Esmolol | |||||||||
Arm description |
24 hours tight heart rate Control with intravenous esmolol infusion | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Esmolol
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Investigational medicinal product code |
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Other name |
Brevibloc
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Successive, body-weight adapted i.v. administration, maximal dose 200μg/kg kg/min as maintenance dose
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Arm title
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Placebo | |||||||||
Arm description |
24 hours intravenous placebo infusion | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo (NaCl 0,9%)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
250ml Infusionslösung
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Baseline characteristics reporting groups
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Reporting group title |
Esmolol
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Reporting group description |
24 hours tight heart rate Control with intravenous esmolol infusion | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
24 hours intravenous placebo infusion | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Esmolol
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Reporting group description |
24 hours tight heart rate Control with intravenous esmolol infusion | ||
Reporting group title |
Placebo
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Reporting group description |
24 hours intravenous placebo infusion |
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End point title |
Maximum change in Troponin-T-concentration from baseline to 48 hours [1] | ||||||||||||
End point description |
ITT population
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End point type |
Primary
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End point timeframe |
48 hours post baseline
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: For statistical analysis see attached summary report |
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Notes [2] - ITT population [3] - ITT population |
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No statistical analyses for this end point |
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End point title |
Time to peak Troponin T | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 48h
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No statistical analyses for this end point |
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End point title |
Area unter the Curve (AUC) of Troponin T release | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 48h
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No statistical analyses for this end point |
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End point title |
6-minute walk test | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
6 weeks and 6 months
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Notes [4] - 49 for 6 weeks, 50 for 6 months [5] - 49 for 6 weeks, 48 for 6 months |
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No statistical analyses for this end point |
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End point title |
Mean heart rate during study intervention | ||||||||||||
End point description |
Heart rate was measuread at 0, 6, 12, 18 and 24 hours.
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End point type |
Secondary
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End point timeframe |
mean value from a 24 hours period
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No statistical analyses for this end point |
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End point title |
Area under the curve (AUC) NT-proBNP | ||||||||||||
End point description |
NT-proBNP: N-terminal pro brain natriuretic peptide.
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End point type |
Secondary
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End point timeframe |
within 0h (baseline) to 48 hours
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No statistical analyses for this end point |
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End point title |
Rehospitalisation | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
6 weeks and 6 months after baseline
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Notes [6] - 49 for 6 weeks, 50 for 6 months |
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No statistical analyses for this end point |
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End point title |
quality of life test | ||||||||||||||||||
End point description |
Change in score between baseline and timepoint
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End point type |
Secondary
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End point timeframe |
6 weeks and 6 months
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Notes [7] - 49 for 6 weeks, 50 for 6 months |
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No statistical analyses for this end point |
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End point title |
Echocardiography-ejection fraction | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
post baseline, after 6 weeks, after 6 months
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Notes [8] - 49 for: ejection fr. after 6 w. and for change in ejection fr. from post-int. to 6 weeks [9] - 49 for ejection fr. after 6 weeks and change post-int. to 6 w. 48 for 6 mths. values |
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No statistical analyses for this end point |
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End point title |
Reintervention | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
6 weeks and 6 months after baseline
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Notes [10] - 49 for 6 weeks, 50 for 60 months |
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No statistical analyses for this end point |
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End point title |
Reinfarction | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
6 weeks and 6 months after baseline
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Notes [11] - 49 for6 weeks time point, 50 for 6 months timepoint |
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No statistical analyses for this end point |
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End point title |
Repeat PCI | |||||||||||||||
End point description |
PCI: percoutaneous coronary intervention
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End point type |
Secondary
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End point timeframe |
PCI 6 weeks and 6 months after baseline
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No statistical analyses for this end point |
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End point title |
Angina pectoris during follow-up | |||||||||||||||||||||||||||
End point description |
CCS: Canadian Cardiovascular Society
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End point type |
Secondary
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End point timeframe |
post-intervention, after 6 weeks, after 6 months
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Notes [12] - 50 post intervention, 49 after 6 weeks, 50 after 6 months [13] - 50 post-intervention, 49 after 6 weeks, 49 after 6 months |
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No statistical analyses for this end point |
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End point title |
Apoplex during follow-up | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
6 weeks and 6 months after baseline
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Notes [14] - 49 subjects at 6 weeks timepoint, 48 subjects at 6 months timepoint |
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No statistical analyses for this end point |
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End point title |
Death from any cause | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
entire study
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No statistical analyses for this end point |
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End point title |
Time to peak concentration NT-proBNP | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 48 hours
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No statistical analyses for this end point |
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End point title |
Neuropsychological status | ||||||||||||||||||
End point description |
change in visual analogue scale (VAS) status compare to baseline
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End point type |
Secondary
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End point timeframe |
6 weeks, 6 months
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Notes [15] - 49 for 6 weeks, 50 for months |
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No statistical analyses for this end point |
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End point title |
Area unter the Curve (AUC) creatinine kinase | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline to 48 hours
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No statistical analyses for this end point |
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End point title |
Time to peak creatinine kinase | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 48 hours
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No statistical analyses for this end point |
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End point title |
Area under the curve (AUC) creatinine kinase MB | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 48 hours
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No statistical analyses for this end point |
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End point title |
Time to peak creatinine kinase MB | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 48 hours
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No statistical analyses for this end point |
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End point title |
Change in endothelial progenitor cells CD34 | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline to 24 hours
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No statistical analyses for this end point |
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End point title |
Change in endothelial progenitor cells KDR | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 24 hours
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No statistical analyses for this end point |
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End point title |
Change in endothelial progenitor cells CD133 | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 48 hours
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No statistical analyses for this end point |
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End point title |
Change in endothelial progenitor cells CD117 | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to 24 hours
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No statistical analyses for this end point |
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End point title |
Echocardiography-wall motion abnormality | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
post-intervention, 6 weeks and 6 months after intervention
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Notes [16] - 49 for 6 weeks values [17] - 49 for 6 weeks and 6 months values |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
AEs from Baseline Visite 1 (0h) to Follow-up Visite 3(6mth)
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17.0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: For Advers Event listing see attached summary report - safety |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |