Clinical Trial Results:
Pharmacokinetic/Pharmacodynamic effects of add-on antiplatelet therapy with parenteral cangrelor as compared to standard dual antiplatelet treatment in patients with ST-elevation myocardial infarction complicated by out-of-hospital cardiac arrest and treated with targeted temperature management – A Randomized Controlled Trial
Summary
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EudraCT number |
2016-003265-26 |
Trial protocol |
AT |
Global end of trial date |
12 Nov 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Apr 2023
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First version publication date |
28 Apr 2023
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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 |
345
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Department of Emergency Medicine, Medical University of Vienna, +43 4040039530, gabriela.hess@meduniwien.ac.at
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Scientific contact |
Department of Emergency Medicine, Medical University of Vienna, +43 4040039530, gabriela.hess@meduniwien.ac.at
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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 |
27 Nov 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Nov 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Nov 2019
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the additive platelet suppressing effect of iv P2Y12r inhibitor cangrelor in cardiac arrest patients with STEMI. In particular, the trial aims to investigate whether the additional iv infusion of cangrelor (as “on top treatment”) is superior (i.e. stronger and faster) to the standard oral P2Y12r inhibitor regimen in terms of suppressing ADP-dependent platelet activation at the time of cardiac intervention (i.e. stent placement) in out-of-hospital cardiac arrest (OHCA) patients with STEMI treated with therapeutic hypothermia (TH).
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Protection of trial subjects |
not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Jan 2017
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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 |
Austria: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
16
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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) |
14
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
We screened all patients admitted to the emergency department of the medical university of vienna for CPR due to suspected ACS | ||||||
Pre-assignment
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Screening details |
not applicable | ||||||
Period 1
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Period 1 title |
Recruitment Period (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
observational study only
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Arms
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Arm title
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Cangrelor Arm | ||||||
Arm description |
observational part | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Cangrelor
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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 |
30µg/kg intravenous bolus, 4µg/kg/min continuous infusion
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Baseline characteristics reporting groups
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Reporting group title |
Recruitment Period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cangrelor Arm
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Reporting group description |
observational part |
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End point title |
patients with HPR at predefined time points during the first 24 hours after cangrelor cessation [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
24h after cangrelor cessation
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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: Only descriptive analysis for primary endpoint, no between group comparison |
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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 |
until hospital discharge
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
22.1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: No adverse events in relation to study drug |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/32098088 |