Clinical Trial Results:
APixaban versus PhenpRocoumon: Oral AntiCoagulation plus antiplatelet tHerapy in patients with Acute Coronary Syndrome and Atrial Fibrillation (APPROACH-ACS-AF)
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Summary
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EudraCT number |
2015-005566-33 |
Trial protocol |
DE |
Global end of trial date |
30 Jun 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Dec 2021
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First version publication date |
13 Dec 2021
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Other versions |
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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 |
CV185-398Wakili
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02789917 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
LMU München
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Sponsor organisation address |
Marchioninistr. 15, Munich, Germany,
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Public contact |
Dr. Viktoria Janke, Muenchner Studienzentrum, 0049 8941407717, viktoria.janke@mri.tum.de
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Scientific contact |
Dr. Viktoria Janke, Muenchner Studienzentrum, 0049 8941407717, viktoria.janke@mri.tum.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 |
30 Jun 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Jun 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jun 2021
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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 an optimal antithrombotic treatment strategy with the best benefit-to-risk ratio with primary endpoint bleeding comparing a dual antithrombotic regimen including clopidogrel plus the FXa inhibitor apixaban versus a guideline conform triple treatment strategy including a vitamin K antagonist plus ASA plus clopidogrel in a predefined high risk population in the context of an ACS (after successful PCI) and the concomitant diagnosis of AF with need for an oral anticoagulation. We postulate that a dual antithrombotic regimen (clopidogrel plus the FXa inhibitor apixaban) is superior to the triple treatment strategy (vitamin K antagonist plus ASA plus clopidogrel) regarding reduction of bleeding events.
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Protection of trial subjects |
Safety monitoring board checking on safety events
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Jul 2016
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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: 403
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Worldwide total number of subjects |
403
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EEA total number of subjects |
403
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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) |
46
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From 65 to 84 years |
200
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85 years and over |
157
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Recruitment
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Recruitment details |
Main criteria for inclusion: - Patients with an ACS after successful percutaneous coronary intervention - Indication for oral anticoagulation due to non- valvular atrial fibrillation or atrial flutter (CHA2DS2VASc score) | |||||||||
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Pre-assignment
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Screening details |
Oral anticoagulation for AF ACS | |||||||||
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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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Control | |||||||||
Arm description |
Phenprocoumon + Clopidogrel for 6 months + Acetylsalicylic acid for 1-6 months (depending on HAS-BLED score/at the discretion of the treating physician) | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Study arm | |||||||||
Arm description |
Apixaban + Clopidogrel for 6 months | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Apixaban + Clopidogrel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Anticoagulant and preservative solution for blood
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Routes of administration |
Oral use
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Dosage and administration details |
as recommended
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Baseline characteristics reporting groups
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Reporting group title |
Control
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Reporting group description |
Phenprocoumon + Clopidogrel for 6 months + Acetylsalicylic acid for 1-6 months (depending on HAS-BLED score/at the discretion of the treating physician) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Study arm
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Reporting group description |
Apixaban + Clopidogrel for 6 months | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Control
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Reporting group description |
Phenprocoumon + Clopidogrel for 6 months + Acetylsalicylic acid for 1-6 months (depending on HAS-BLED score/at the discretion of the treating physician) | ||
Reporting group title |
Study arm
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Reporting group description |
Apixaban + Clopidogrel for 6 months | ||
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End point title |
BARC≥2 Bleeding | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
whole study period
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Statistical analysis title |
Log-Rank Test | |||||||||
Comparison groups |
Study arm v Control
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Number of subjects included in analysis |
403
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
≤ 5 | |||||||||
Method |
Logrank | |||||||||
Parameter type |
Hazard ratio (HR) | |||||||||
Confidence interval |
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End point title |
composite clinical efficacy outcome | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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| No statistical analyses for this end point | ||||||||||
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End point title |
net clinical outcome | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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| No statistical analyses for this end point | ||||||||||
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End point title |
all cause death | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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| No statistical analyses for this end point | ||||||||||
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End point title |
ischmia | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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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 |
Begin of study until 30 days after completion of trial
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
database | ||
Dictionary version |
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: Due to the trial design many non-serious adverse events were documented. A extra document can be attached if desired. |
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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 | |||
