Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005887

Trial Description

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Title

Influence of Rivaroxaban Compared to Vitamin K Antagonist Treatment Upon Development of Cardiovascular Calcification in Patients With Atrial Fibrillation and/ or Pulmonary Embolism

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

A single center, prospective, controlled, open, randomized, interventional clinical trial
blinded concerning outcome measurements with a two- arm parallel group design will be
performed to investigate the association of rivaroxaban compared to coumadin/phenprocoumon
treatment for OAT in patients with atrial fibrillation and / or pulmonary embolism regarding
the development and progression of coronary artery calcification (CAC) and aortic valve
calcification (AVC) as assessed by multi-slice spiral computed tomography scanning (MSCT)
within one year follow-up. In total 348 patients (174 patients per treatment arm including
calculated drop outs and invalid cases) with atrial fibrillation and/ or pulmonary embolism
with the indication for oral anticoagulation therapy will be enrolled. After screening first
cardiac CT scan will be performed in order to validate if calcium score is >50 which is an
inclusion criteria. If the patient matches all other inclusion/exclusion criteria the
remaining imaging procedures (Echocardiography, Intima Media Thickness of carotid artery
(IMT) and Flow Mediated Vasodilatation (FMD), Electrocardiography (ECG) and blood pressure
are executed. Pregnancy strip test will be executed and also serum chemistry, hematology,
coagulation and batch analysis will be performed. Patients will then be randomized to one of
the two arms (Rivaroxaban or Marcumar) and will undergo the same examinations and
measurements as described above at 1 week, 1, 6, 9 and 12 month Follow- Up (FU). In case of
a positive result in respect to the primary endpoint a FU after 2 years will be performed
optionally.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005887
  •   2015/02/19
  •   2014/02/17
  •   yes
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Secondary IDs

  •   NCT02066662  (ClinicalTrials.gov)
  •   12-001  (RWTH Aachen University)
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Health Condition or Problem studied

  •   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
  •   I48.9 -  [generalization I48: Atrial fibrillation and flutter]
  •   I26 -  Pulmonary embolism
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Interventions/Observational Groups

  •   Drug: Rivaroxaban or Marcumar
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Basic research/physiological study
  •   Parallel
  •   IV
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Primary Outcome

- Progression of coronary and aortic valve calcification (Agatston Score); time frame: Cardiac Computertomography (CT) will be performed at screening, after 12 months and optional at 24 months; To investigate the association of rivaroxaban compared to coumadin/phenprocoumon treatment for OAT in patients with atrial fibrillation and / or pulmonary embolism regarding the development and progression of coronary artery calcification (CAC) and aortic valve calcification (AVC) as assessed by multi-slice spiral computed tomography scanning (MSCT) within one year follow-up

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Secondary Outcome

- Serum chemistry including Matrix Gla Protein (MPG) level changes and Fetuin-A (baseline/ follow up); time frame: baseline and 12 month Follow Up
- Changes in intima-media thickness of carotid artery (IMT) and flow-mediated vasodilation of brachial artery (FMD); time frame: Baseline, 6, 9 and 12 month FU
- Progression of aortic calcification (aortic Agatston Score); time frame: screening and 12 month FU
- Changes in ventricular diastolic function parameters as determined by echocardiography (strain/strain-rate imaging); time frame: baseline, 6, 9 and 12 month FU

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/07/31
  •   348
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Male or female patient aged > 18 years

2. Need for long-term OAT according to current international guidelines for the
treatment of atrial fibrillation (ACC/(American Heart Association [AHA]/ European
Society of Cardiology [ESC]guidelines) and / or pulmonary embolism (ACCP/ESC
guidelines).

3. Existent Coronary or Valvular Calcification, or both and an Agatston Score > 50 in at
least one location as assessed by MSCT at Screening

4. PROCAM Score ≥ 29

5. The anticipated minimum life expectancy is18 months

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Exclusion Criteria

1. Patient has any clinical condition which does not allow initiation of long-term OAT
including all contraindications such as hypersensitivity to active ingredient or
other excipients, clinically relevant acute bleedings and all other risk
circumstances according to Summary of Medicinal Product (SmPC) in which all warnings
and preventive measures and precautions are described and have to be kept.

2. Hypersensitivity to active substances investigated or to any of the excipients

3. Patients had a previous coronary stent implantation and no Valvular Calcification
with Agatston Score > 50

4. Chronic kidney disease (CKD) Stage V (GFR <15 mL)

5. Liver disease with coagulopathy or other bleeding disorders including cirrhotic
patients with Child Pugh B and C

6. Acute gastrointestinal diseases

7. Clinically significant active bleeding

8. Alcohol, opioids or drug abuse

9. Mental condition rendering the patient unable to understand the nature, scope and
possible consequences of the study

10. Patient is unwilling or unable to give informed consent

11. Patient is unlikely to comply with protocol, e.g. uncooperative attitude, inability
to return for follow-up visits, and unlikelihood of completing the study

12. Participation in a parallel interventional clinical trial

13. Patient has been committed to an institution by legal or regulatory order

14. Pregnant or lactating women

15. Female patient capable of bearing children without highly effective methods of birth
control

16. Patient receives concomitant treatment with strong concurrent Cytochrome P 450 3A4
(CYP3A4)- and P- glycoprotein (P-gp)- inhibitors, i.e. azole-antimycotics
(ketoconazole, itraconazole) or human immunodeficiency virus (HIV) protease
inhibitors

17. Neuraxial Anaesthesia or spinal/epidural puncture

18. Known Endocarditis

19. Known Lactose intolerance

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Addresses

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    • RWTH Aachen University
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    • Bayer
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    • Ralf Koos, PD Dr. med. 
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    • Ralf Koos, PD Dr. med. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.