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Rivaroxaban Compared to Vitamin K Antagonist Upon Development of Cardiovascular Calcification

NCT02066662 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2020-10-22

No results posted yet for this study

Summary

The following trial hypothesis will be proved: In patients with atrial fibrillation and/ or pulmonary embolism standard anticoagulant treatment with coumadin/phenprocoumon is associated with accelerated coronary or valvular calcification as assessed by cardiac computed tomography compared to the new anticoagulant therapy with rivaroxaban.

Conditions

  • Atrial Fibrillation or Pulmonary Embolism
  • Need 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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • RWTH Aachen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT02066662 on ClinicalTrials.gov