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

NCT02789917 | Completed Phase 4 DMC

• 1 other identifier: GE IDE MucT003-16
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 16

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.

Conditions

Acute Coronary Syndrome; Atrial Fibrillation; Coronary Artery Disease

Keywords

ACS; Triple-Therapy; AF; oral anticoagulation (OAC); non-vitamin-K oral anticoagulant (NOAC)

Outcome Measures

Primary Outcomes (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)

  up to 6 months after randomization

Secondary Outcomes (2)

• Combined event of death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism and all the individual components of the composite secondary endpoint

  up to 6 months after randomization

• Bleeding complications (Major bleeding: BARC > 3b bleeding)

  up to 6 months after randomization

Study Arms (2)

Dual therapy (incl. NOAC)

EXPERIMENTAL

Apixaban plus Clopidogrel

Other: Dual Therapy

Triple therapy (incl. VKA)

ACTIVE COMPARATOR

Phrenprocoumon plus Clopidogrel plus ASA

Other: Triple Therapy

Interventions

Dual Therapy OTHER

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.

Dual therapy (incl. NOAC)

Triple Therapy OTHER

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.

Triple therapy (incl. VKA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LMU Klinikum: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• Technical University of Munich: collaborator
• Helmholtz Zentrum München: collaborator
• University of Göttingen: collaborator
• University of München: collaborator
• University Medicine Greifswald: collaborator

Study Sites (16)

Munich University Hospital

Munich, Bavaria, 81377, Germany

Location

Universitätsklinikum der RWTH Aachen

Aachen, Germany

Location

Charité, Campus Benjamin Franklin

Berlin, Germany

Location

Charité, Campus Virchow-Klinikum

Berlin, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

Westdeutsches Herzzentrum am Universitätsklinikum

Essen, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Universitätsmedizin Greifswald

Greifswald, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

UKHS Campus Kiel

Kiel, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, Germany

Location

Universitätsmedizin Mainz

Mainz, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Klinikum Augustinum

München, Germany

Location

Städtisches Klinikum München-Neuperlach

München, Germany

Location

Universitätsmedizin Rostock

Rostock, Germany

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Atrial Fibrillation; Coronary Artery Disease

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Reza Wakili, MD

  Klinikum der Universität München (LMU)

  PRINCIPAL INVESTIGATOR

• Steffen Massberg, Prof.

  Klinikum der Universität München (LMU)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med. Reza Wakili

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 3, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (16)