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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 29, 2008

Last Updated Date

March 21, 2013

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00782743 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

Official Title ^ICMJE

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

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

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Biomarkers for inflammation, measuring of inhibitors of calcification

Sampling Method

Non-Probability Sample

Study Population

Patients with required therapy with either ASS or phenprocoumon

Condition ^ICMJE

Valvular Calcification
Coronary Calcification

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00782743

Other Study ID Numbers ^ICMJE

Marcumar-ASS-Study, Eudra-CT-Number 2007-001685-33, Study-Number 07/002

Has Data Monitoring Committee

Responsible Party

RWTH Aachen University

Study Sponsor ^ICMJE

RWTH Aachen University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ralf Koos, MD

RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

Information Provided By

RWTH Aachen University

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top