Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

NCT ID: NCT00782743

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2015-08-31

Brief Summary

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

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.

Conditions

Valvular Calcification; Coronary Calcification

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

patients with required new anticoagulation with phenprocoumon 1/2 of them with a GFR\< 60 ml/min and \>15 ml/min

No interventions assigned to this group

2

patients with required therapy with ASS, 1/2 of them with a GFR \<60 ml/min and \>15 ml/min

No interventions assigned to this group

Eligibility 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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Brandenburg, Prof.

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

Locations

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Eudra-CT-Number 2007-001685-33

Identifier Type: -

Identifier Source: secondary_id

Study-Number 07/002

Identifier Type: -

Identifier Source: secondary_id

Marcumar-ASS-Study

Identifier Type: -

Identifier Source: org_study_id