- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789917
APixaban vs. PhenpRocoumon in Patients With ACS and AF: APPROACH-ACS-AF (APPROACH)
August 12, 2020 updated by: Reza Wakili, LMU Klinikum
APixaban Versus PhenpRocoumon: Oral AntiCoagulation Plus Antiplatelet tHerapy in Patients With Acute Coronary Syndrome and Atrial Fibrillation
It is hypothesised that a dual therapy strategy by oral anticoagulation with the new Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding bleeding events in patients with atrial fibrillation undergoing percutaneous coronary intervention in the setting of an acute coronary syndrome.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients with atrial fibrillation (AF) presenting an acute coronary syndrome (ACS) and undergoing PCI require a triple therapy with a combination of oral anticoagulation (OAC) and dual anti-platelet therapy.
Current guidelines recommend a regimen consisting of aspirin, clopidogrel and an oral anticoagulant.
Although effective in preventing recurrent ischemia, triple therapy confers an elevated bleeding risk, which also has a major impact on the patients' prognosis and survival.
Data from one randomized trial suggest that omitting aspirin in patients with indication for triple therapy may reduce the risk of bleeding without an increase of the rate of ischemic events.
In addition, the recently introduced non-vitamin-K oral anticoagulants (NOACs) show less bleeding events as compared to vitamin-K antagonist in AF patients.
In this trial it is postulated that a dual therapy consisting of the factor-Xa inhibitor apixaban and clopidogrel is associated with significant lower bleeding rates as compared to traditional triple therapy with aspirin, clopidogrel and a vitamin K antagonist (VKA).
To test this hypothesis, patients with atrial fibrillation, who underwent PCI in the setting of an ACS will be randomized to either a dual therapy (apixaban+clopidogrel) or a triple therapy (aspirin+clopiodgrel+VKA). The patients will be followed-up for 6 months after randomization.
Study Type
Interventional
Enrollment (Actual)
403
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aachen, Germany
- Universitatsklinikum der RWTH Aachen
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Berlin, Germany
- Charite, Campus Benjamin Franklin
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Berlin, Germany
- Charité, Campus Virchow-Klinikum
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Coburg, Germany
- Klinikum Coburg
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Essen, Germany
- Westdeutsches Herzzentrum am Universitätsklinikum
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Greifswald, Germany
- Universitätsmedizin Greifswald
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Göttingen, Germany
- Universitätsmedizin Göttingen
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Heidelberg, Germany
- Universitätsklinikum Heidelberg
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Kiel, Germany
- UKHS Campus Kiel
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Lüdenscheid, Germany
- Klinikum Lüdenscheid
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Mainz, Germany
- Universitätsmedizin Mainz
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Mannheim, Germany
- Universitätsklinikum Mannheim
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München, Germany
- Klinikum Augustinum
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München, Germany
- Städtisches Klinikum München-Neuperlach
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Rostock, Germany
- Universitätsmedizin Rostock
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Bavaria
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Munich, Bavaria, Germany, 81377
- Munich University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion 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.
Exclusion Criteria:
- Age < 18 years
- History of intracranial bleeding
- Active bleeding
- History of TIMI major bleeding according to TIMI and/or type ≥3b BARC criteria in the last 6 months
- History of peptic ulcer in the last 6 months
- Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to randomization. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamine) for ≥7 days
- Planned major surgery during the study course with planned discontinuation of antithrombotic therapy
- Expected life expectancy of less than a year and/or severe illness (e.g. malignancy)
- Mechanical valve replacement
- Valvular atrial fibrillation
- Severe renal insufficiency (creatinine clearance < 30ml/min)
- Severe liver insufficiency (Child-Pugh-class C) or elevated hepatic transaminases >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 < 50 G/L or 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual therapy (incl. NOAC)
Apixaban plus Clopidogrel
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Combination of Apixaban 5mg/dl (or in reduced dosing of 2.5 mg/d depending on age, renal function and body weight) in combination with Clopidogrel 75 mg/d for 6 months.
|
Active Comparator: Triple therapy (incl. VKA)
Phrenprocoumon plus Clopidogrel plus ASA
|
HAS-BLED-Score <3: Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 6 months. HAS-BLED-Score ≥ 3: Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 1 month followed by Phrenprocoumon (INR 2.0-3.0) and Clopidogrel (75mg/d) for 5 months. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The combined endpoint of moderate or major bleeding complications during the initial hospitalization and follow up (Bleeding Academic Research Consortium (BARC) type ≥ 2 bleeding)
Time Frame: up to 6 months after randomization
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up to 6 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Combined event of death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism and all the individual components of the composite secondary endpoint
Time Frame: up to 6 months after randomization
|
up to 6 months after randomization
|
Bleeding complications (Major bleeding: BARC > 3b bleeding)
Time Frame: up to 6 months after randomization
|
up to 6 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Reza Wakili, MD, Klinikum der Universität München (LMU)
- Study Chair: Steffen Massberg, Prof., Klinikum der Universität München (LMU)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
May 24, 2016
First Submitted That Met QC Criteria
May 30, 2016
First Posted (Estimate)
June 3, 2016
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE IDE MucT003-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Inclusion in central DZHK Database (German Centre for Cardiovascular Research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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