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

NCT02789917 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2020-08-14

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • Helmholtz Zentrum München

    collaborator INDUSTRY

  • University of Göttingen

    collaborator OTHER

  • University of München

    collaborator OTHER

  • University Medicine Greifswald

    collaborator OTHER

  • LMU Klinikum

    lead OTHER

Principal Investigators

  • Reza Wakili, MD · Klinikum der Universität München (LMU)

  • Steffen Massberg, Prof. · Klinikum der Universität München (LMU)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789917 on ClinicalTrials.gov