Clinical Trial Results:
A prospective, randomized, parallel-group, open label, non-inferiority, multicenter trial of a 12 month vs. a short-term platelet function testing guided prasugrel therapy in acute coronary syndrome patients undergoing coronary stenting
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Summary
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EudraCT number |
2013-001636-22 |
Trial protocol |
DE HU AT PL |
Global end of trial date |
15 May 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Jul 2018
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First version publication date |
27 Jul 2018
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Other versions |
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Summary report(s) |
Clinical Study 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 |
TROPICALACS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01959451 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Hospital of the University of Munich, Grosshadern
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Sponsor organisation address |
Marchioninistr.15, Munich, Germany,
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Public contact |
I. Med. Klinik und Poliklinik, Hospital of the University of Munich, Grosshadern, +49 89440072371,
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Scientific contact |
I. Med. Klinik und Poliklinik, Hospital of the University of Munich, Grosshadern, +49 89440072371,
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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 |
08 May 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 May 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
15 May 2017
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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 |
A Platelet function testing guided approach with a short-term (1 week) post hospital discharge prasugrel maintenance dose treatment and a switch-over to clopidogrel treatment in adequate responders to the drug is non-inferior to the currently recommended long-term (12 month) treatment with prasugrel in ACS patients undergoing PCI.
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Protection of trial subjects |
Every subject participating in the trial was insured against any trial-related illness/injuries pursuant to the legal requirements which may occur during the trial.
Name of Insurer: HDI-Gerling Industrieversicherung AG
Insurance Number: 39 130537 03026
Address: Niederlassung Düsseldorf
Am Schönenkamp 45, D-40599 Düsseldorf
Phone: +49 (0)211/7482-5419
Fax: +49 (0)211/7482-465
This insurance covered trial related injuries to health up to a maximum of 500.000
Euro per subject.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Nov 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 |
Germany: 1440
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Country: Number of subjects enrolled |
Hungary: 878
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Country: Number of subjects enrolled |
Austria: 72
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Country: Number of subjects enrolled |
Poland: 220
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Worldwide total number of subjects |
2610
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EEA total number of subjects |
2610
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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) |
1821
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From 65 to 84 years |
789
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85 years and over |
0
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Recruitment
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Recruitment details |
see document attached | |||||||||
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Pre-assignment
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Screening details |
Patients with an ACS (positive for troponin) after successful percutaneous coronary intervention with an indication for standard treatment of 12 month with prasugrel. | |||||||||
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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 |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Guided de-escalation | |||||||||
Arm description |
Guided de-escalation of DAPT | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Clopidogrel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
p.o.
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Arm title
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Control | |||||||||
Arm description |
control group | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Prasugrel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
p.o.
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End points reporting groups
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Reporting group title |
Guided de-escalation
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Reporting group description |
Guided de-escalation of DAPT | ||
Reporting group title |
Control
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Reporting group description |
control group | ||
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End point title |
primary endpoint | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 months
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Statistical analysis title |
kaplan meier | |||||||||
Statistical analysis description |
´Kaplan meier
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Comparison groups |
Guided de-escalation v Control
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Number of subjects included in analysis |
2610
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Confidence interval |
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| Notes [1] - non-inferiority |
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Adverse events information [1]
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Timeframe for reporting adverse events |
within 24 hours
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
16-20.1
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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: please see document attached |
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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 | |||
