Clinical Trial Results:
The effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)- a four arm randomised controlled trial
Summary
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EudraCT number |
2013-001922-24 |
Trial protocol |
GB |
Global end of trial date |
03 Jun 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Nov 2020
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First version publication date |
12 Nov 2020
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Other versions |
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 |
120541
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01864252 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University College London
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Sponsor organisation address |
ower St, Bloomsbury, London, United Kingdom, WC1E 6BT
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Public contact |
Prof. Derek M Yellon, The Hatter Cardiovascular Institute, 0044 000, d.yellon@ucl.ac.uk
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Scientific contact |
Prof. Derek M Yellon, The Hatter Cardiovascular Institute, 0044 000, d.yellon@ucl.ac.uk
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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 |
03 Jun 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Jun 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jun 2019
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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 |
1. Does GTN administered as a continuous (intra-operative intravenous) infusion into a vein reduce injury to the heart muscle in patients undergoing heart-lung bypass Coronary Artery Bypass Graft (CABG) and/or valve surgery?
2. Does RIPC reduce injury to the heart muscle in the presence of GTN administered as a continuous (intra-operative intravenous) infusion into a vein in patients undergoing heart-lung bypass CABG and/or valve surgery?
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Protection of trial subjects |
N/A
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Background therapy |
GTN vs Placebo | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
United Kingdom: 194
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Worldwide total number of subjects |
194
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EEA total number of subjects |
194
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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) |
57
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From 65 to 84 years |
112
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85 years and over |
25
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Recruitment
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Recruitment details |
Patient assessment prior to their elective admission | |||||||||||||||
Pre-assignment
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Screening details |
Patient were screened prior to their elective admission using the elective cardiac surgery lists. | |||||||||||||||
Period 1
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Period 1 title |
Full period
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Data analyst | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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RIP+Placebo | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
as per anesthetic team
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Arm title
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RIC+GTN | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
GTN
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
As per anesthetic team
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Arm title
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Sham+GTN | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
as per anesthetic team
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Investigational medicinal product name |
GTN
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
As per anesthetics
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Arm title
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Sham+Placebo | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
as per anesthetic team
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Period 2
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Period 2 title |
baseline period
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Is this the baseline period? |
Yes [1] | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Data analyst | |||||||||||||||
Arms
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Arm title
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Sham and GTN | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
GTN
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
As per anesthetics
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Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: PERIOD 1 is the baseline period. |
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Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: these are consistent [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: This is due to drop outs and those who did not complete the trial. |
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End points reporting groups
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Reporting group title |
RIP+Placebo
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Reporting group description |
- | ||
Reporting group title |
RIC+GTN
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Reporting group description |
- | ||
Reporting group title |
Sham+GTN
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Reporting group description |
- | ||
Reporting group title |
Sham+Placebo
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Reporting group description |
- | ||
Reporting group title |
Sham and GTN
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Reporting group description |
- |
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End point title |
Area under the curve for mean troponin [1] | ||||||||||||||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
01/2013 - 01/2019
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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: statistical analysis was undertaken |
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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 |
03/2013 - 06/2019
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
2.0
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Reporting groups
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Reporting group title |
Adverse event
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||
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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: Only SAEs occurred in the trial no non -serious adverse events |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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02 Feb 2015 |
Adding substudy |
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20 Aug 2015 |
Removing 72H tropinin level from trial |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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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 |