Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA) - Full Text View

Sponsored by:	RWTH Aachen University
Information provided by:	RWTH Aachen University
ClinicalTrials.gov Identifier:	NCT00782743

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

Drug Information available for: Acetylsalicylic acid Salicylic acid Phenprocoumon

U.S. FDA Resources

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

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

Biospecimen Description:

Biomarkers for inflammation, measuring of inhibitors of calcification

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2011

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

anticoagulation with phenprocoumon (needed for at least 1 year)
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

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

Contacts

Contact: Ralf Koos, MD

++49 241 ext 8035624

rkoos@ukaachen.de

Locations

Germany, NRW
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine	Recruiting
Aachen, NRW, Germany, 52074
Contact: Ralf Koos, MD ++49 241 ext 8035624 rkoos@ukaachen.de

Sponsors and Collaborators

RWTH Aachen University

Investigators

Principal Investigator:

Ralf Koos, MD

RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

More Information

Responsible Party:	RWTH Aachen University ( Ralf Koos, MD )
Study ID Numbers:	Marcumar-ASS-Study, Eudra-CT-Number 2007-001685-33, Study-Number 07/002
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782743
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

Study placed in the following topic categories:

Calcinosis
Metabolic Diseases
Phenprocoumon

Aspirin
Salicylic Acid
Metabolic disorder

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Calcium Metabolism Disorders

Fibrin Modulating Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009