Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00782743
First received: October 29, 2008
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

In this open, prospective, non-randomised, parallel group, unicentric pilot-study will be compared the progress of valvular and coronary calcification with regard to the therapy with either acetyl-salicylic acid or phenprocoumon. The progress of calcification is documented by comparison of cardial stratified computed tomography. It is supposed that treatment with phenprocumon leads to increased coronary and valvular calcification as well to decreased blood levels of carboxylated matrix-GLA-protein


Condition
Valvular Calcification
Coronary Calcification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Progression of coronary and valvular calcification confirmed by computed tomography [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biomarkers for inflammation, measuring of inhibitors of calcification


Estimated Enrollment: 120
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients with required new anticoagulation with phenprocoumon 1/2 of them with a GFR< 60 ml/min and >15 ml/min
2
patients with required therapy with ASS, 1/2 of them with a GFR <60 ml/min and >15 ml/min

Detailed Description:

Patients will be allocated to two groups with either

  1. anticoagulation with phenprocoumon (needed for at least 1 year)
  2. therapy with ASA

Both treatment groups should include to 50% patients with a glomerular filtration rate (GFR) < 60 ml/min and > 15 ml/min.

All patients will undergo a screening procedure with evaluation of calcium regulating proteins, echocardiography and stratified computed tomography of the heart. Medical check up's are planned after 1,3,6, 12 and 18 months.

Prior investigations concern diastolic ventricular function under long lasting therapy with phenprocoumon and the influence of long lasting therapy with phenprocoumon in patients suffering from aortic valve sclerosis.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with required therapy with either ASS or phenprocoumon

Criteria

Inclusion Criteria:

  • 60 patients with new onset of anticoagulation therapy with phenprocoumon for the expectant duration of at least one year
  • BMI 19-27 kg/qm
  • Mental ability and capacity to understand and follow the instructions of the investigator
  • Written informed consent

Exclusion Criteria:

  • Patients not fulfilling the inclusion criteria or with:

    • renal failure grade IV or V
    • acute cardial or pulmonary decompensation
    • women of childbearing age, pregnant or breastfeeding women
    • psychiatric diseases
    • life expectancy < 1 year
    • acute lifethreatening situations
    • participation in other studies
    • persons in dependency from the sponsor or working with the sponsor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782743

Locations
Germany
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Ralf Koos, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00782743     History of Changes
Other Study ID Numbers: Marcumar-ASS-Study, Eudra-CT-Number 2007-001685-33, Study-Number 07/002
Study First Received: October 29, 2008
Last Updated: March 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
phenprocoumon
anticoagulation
acetylic salicylic acid
Need for new anticoagulation treatment

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Aspirin
Phenprocoumon
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anticoagulants

ClinicalTrials.gov processed this record on September 18, 2014