Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

September 22, 2015 updated by: RWTH Aachen University

Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- NRW
  - Aachen, NRW, Germany, 52074
    - Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with required therapy with either ASS or phenprocoumon

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression of coronary and valvular calcification confirmed by computed tomography Time Frame: 18 months	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

Principal Investigator: Vincent Brandenburg, Prof., RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria