NCT02066662 - Rivaroxaban Compared to Vitamin K Antagonist Upon Development of Cardiovascular Calcification | Biotech Hunter

Enrollment

192

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

March 31, 2020

Study Completion Date

March 31, 2020

Conditions

Atrial Fibrillation or Pulmonary EmbolismNeed of Long Term Oral Anticoagulation Therapy (OAT)Existent Coronary or Valvular Calcification, or Both and Agatston Score > 50 in at Least One Location

Interventions

DRUG

Rivaroxaban or Marcumar

"Arm A: Rivaroxaban (tablet) for patients with atrial fibrillation: with 20 mg once daily for patients with eGFR \> 49 ml per minute and 15 mg rivaroxaban once daily for patients with eGFR of 15 to 49 ml. Rivaroxaban (tablet) for patients with pulmonary embolism : 2x a day 15 mg at day 1-21 and 1x 20 mg from day 22 ongoing;~Arm B: Adjusted dose coumadin/phenprocoumon (tablet) titrated according to target international normalized ratio (INR) with a target range 2.0 to 3.0."

Trial Locations (3)

52074

University Hospital Aachen, Department of Cardiology, Aachen

52249

St.-Antonius-Hospital Eschweiler, Internal Medicine, Eschweiler

96450

Hospital Coburg, Med. Clinic II for Internal Medicine and Cardiology, Coburg