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APixaban vs. PhenpRocoumon in Patients With ACS and AF: APPROACH-ACS-AF (APPROACH)

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ClinicalTrials.gov Identifier: NCT02789917
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Technische Universität München
Helmholtz Zentrum München
University of Göttingen
University of München
University Medicine Greifswald
Information provided by (Responsible Party):
Reza Wakili, Klinikum der Universitaet Muenchen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Atrial Fibrillation Coronary Artery Disease Other: Dual Therapy Other: Triple Therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: APixaban Versus PhenpRocoumon: Oral AntiCoagulation Plus Antiplatelet tHerapy in Patients With Acute Coronary Syndrome and Atrial Fibrillation
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Dual therapy (incl. NOAC)
Apixaban plus Clopidogrel
Other: Dual Therapy
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
Other: Triple Therapy

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.





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Bleeding complications (Major bleeding: BARC > 3b bleeding) [ Time Frame: up to 6 months after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789917


Contacts
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Contact: Reza Wakili, MD +49 89 4400 ext 73036 reza.wakili@med.uni-muenchen.de
Contact: Lisa Riesinger, MD +49 89 4400 ext 0 Lisa.Riesinger@med.uni-muenchen.de

Locations
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Germany
Munich University Hospital Recruiting
Munich, Bavaria, Germany, 81377
Contact: Reza Wakili, MD    +49894400 ext 73036    reza.wakili@med.uni-muenchen.de   
Contact: Lisa Maria Riesinger, MD    +49894400 ext 0    Lisa_Maria.Riesinger@med.uni-muenchen.de   
Universitätsklinikum der RWTH Aachen Recruiting
Aachen, Germany
Charité, Campus Virchow-Klinikum Recruiting
Berlin, Germany
Klinikum Coburg Recruiting
Coburg, Germany
Westdeutsches Herzzentrum am Universitätsklinikum Recruiting
Essen, Germany
Universitätsmedizin Greifswald Recruiting
Greifswald, Germany
Universitätsmedizin Göttingen Not yet recruiting
Göttingen, Germany
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
UKHS Campus Kiel Recruiting
Kiel, Germany
Klinikum Lüdenscheid Not yet recruiting
Lüdenscheid, Germany
Universitätsmedizin Mainz Recruiting
Mainz, Germany
Klinikum Augustinum Recruiting
München, Germany
Städtisches Klinikum München-Neuperlach Not yet recruiting
München, Germany
Universitätsmedizin Rostock Recruiting
Rostock, Germany
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Technische Universität München
Helmholtz Zentrum München
University of Göttingen
University of München
University Medicine Greifswald
Investigators
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Principal Investigator: Reza Wakili, MD Klinikum der Universität München (LMU)
Study Chair: Steffen Massberg, Prof. Klinikum der Universität München (LMU)

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Responsible Party: Reza Wakili, PD Dr. med. Reza Wakili, Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT02789917     History of Changes
Other Study ID Numbers: GE IDE MucT003-16
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Inclusion in central DZHK Database (German Centre for Cardiovascular Research)

Keywords provided by Reza Wakili, Klinikum der Universitaet Muenchen:
ACS
Triple-Therapy
AF
oral anticoagulation (OAC)
non-vitamin-K oral anticoagulant (NOAC)

Additional relevant MeSH terms:
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Anticoagulants
Syndrome
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Apixaban
Phenprocoumon
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors