APixaban versus PhenpRocoumon: Oral AntiCoagulation plus antiplatelet tHerapy in patients with Acute Coronary Syndrome and Atrial Fibrillation (APPROACH-ACS-AF)

APixaban versus PhenpRocoumon: Oral AntiCoagulation plus antiplatelet tHerapy in patients with Acute Coronary Syndrome and Atrial Fibrillation (APPROACH-ACS-AF) - APPROACH-ACS-AF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005566-33-DE

Enrollment

400

Registered

2016-02-04

Start date

2016-06-14

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute coronary syndrome and atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Eliquis Product Name: Eliquis Pharmaceutical Form: Film-coated tablet INN or Proposed INN: APIXABAN CAS Number: 503612-47-3 Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects will only be included in the study if they meet all of the following criteria: - Signed written informed consent - Patients with an ACS after successful percutaneous coronary intervention - Indication for oral anticoagulation due to non-valvular atrial fibrillation or atrial flutter (CHA2DS2VASc score = 2) - Males and Females, ages = 18 - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. - Women must not be breastfeeding - WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs plus 30 days (duration of ovulatory cycle) post-treatment completion. However they must still undergo pregnancy testing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria: Subjects will not be included in the study if any of the following criteria applies: • Age 2 times the upper limit of normal • Patient’s inability to fully comply with the study protocol • Known or persistent abuse of medication, drugs or alcohol reliable by the investigator in individual cases • Subjects with known contraindications to apixaban, phenprocoumon, clopidogrel or ASA treatment, which are hypersensitive to the drug substance or any component of the product • Relevant hematologic deviations: platelet count 600 G/L • Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: Assessment of efficacy of the assigned therapy in regard to prevent thrombotic coronary events by the antiplatelet therapy and systemic thrombotic events by oral anticoagulation. ;Primary end point(s): Bleeding events according to BARC criteria type =2;Timepoint(s) of evaluation of this end point: until 6 months after randomisation	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: Assessment of efficacy of the assigned therapy in regard to prevent thrombotic coronary events by the antiplatelet therapy and systemic thrombotic events by oral anticoagulation. ;Primary end point(s): Bleeding events according to BARC criteria type =2;Timepoint(s) of evaluation of this end point: until 6 months after randomisation

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Secondary

Measure	Time frame
Secondary end point(s): 1) Composite clinical efficacy outcome: all-cause death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism 2) Net clinical outcome: all-cause death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism or BARC > 3b bleeding) 3) individual components of the composite secondary endpoint 4) cardiovascular death 5) any bleeding episodes (according to Thrombolysis in Myocardial Infarction (TIMI) and BARC criteria) ;Timepoint(s) of evaluation of this end point: To determine differences within all the other interesting secondary endpoints of the study between control versus the experimental arm of the study patients will be followed the entire six months study timeframe.	—

Measure

Time frame

Secondary end point(s): 1) Composite clinical efficacy outcome: all-cause death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism 2) Net clinical outcome: all-cause death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism or BARC > 3b bleeding) 3) individual components of the composite secondary endpoint 4) cardiovascular death 5) any bleeding episodes (according to Thrombolysis in Myocardial Infarction (TIMI) and BARC criteria) ;Timepoint(s) of evaluation of this end point: To determine differences within all the other interesting secondary endpoints of the study between control versus the experimental arm of the study patients will be followed the entire six months study timeframe.

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Countries

Germany

Contacts

Public ContactDr. Viktoria Janke

Muenchner Studienzentrum

viktoria.janke@mri.tum.de00498941407717

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026