Apixaban versus Phenprocoumon: oral anticoagulation plus antiplatelet therapy in patients with acute coronary syndrome and atrial fibrillation (APPROACH-ACS-AF-DZHK7)

ID

NCT02789917

Status

Closed

DZG

DZHK

Start date

06/01/2016

Contact

Contacts
  • Reza Wakili
  • Steffen Massberg

Parameters

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