Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

NCT00782743 | Completed

• 3 other identifiers: Marcumar-ASS-StudyEudra-CT-Number 2007-001685-33Study-Number 07/002
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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

Conditions

Valvular Calcification; Coronary Calcification

Keywords

phenprocoumon; anticoagulation; acetylic salicylic acid; Need for new anticoagulation treatment

Outcome Measures

Primary Outcomes (1)

• Progression of coronary and valvular calcification confirmed by computed tomography

  18 months

Secondary Outcomes (1)

• Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography)

  18 months

Study Arms (2)

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with required therapy with either ASS or phenprocoumon

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

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

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers for inflammation, measuring of inhibitors of calcification

Study Officials

• Vincent Brandenburg, Prof.

  RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

DE (1)