Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

Coronary Calcification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782743
• Other study ID #: Marcumar-ASS-Study
• Secondary ID: Eudra-CT-Number
• Status: Completed
• Phase: N/A
• First received: October 29, 2008
• Last updated: September 22, 2015
• Start date: February 2008
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Calcinosis
• Coronary Calcification
• Valvular Calcification

Locations

Country	Name	City	State
Germany	Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of coronary and valvular calcification confirmed by computed tomography		18 months	No
Secondary	Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography)		18 months	No