Valvular CalcificationNCT00782743
Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)
An observational study of Valvular Calcification and Coronary Calcification, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Valvular Calcification, Coronary Calcification
- How many people
- 157 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with required therapy with either ASS or phenprocoumon
Who may be able to join
- 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
Who cannot join
- 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
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- acute lifethreatening situations
- participation in other studies
- persons in dependency from the sponsor or working with the sponsor
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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
Read the 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.
- Conditions
- Valvular Calcification, Coronary Calcification
- Keywords
- phenprocoumon, anticoagulation, acetylic salicylic acid, Need for new anticoagulation treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Progression of coronary and valvular calcification confirmed by computed tomography
Measured: 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)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Brandenburg, Prof., Principal investigator, RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782743
- Sponsor's protocol ID
- Marcumar-ASS-Study
- Other IDs
- Eudra-CT-Number 2007-001685-33, Study-Number 07/002
- Status last verified
- Sep 2015
- First submitted
- 29 Oct 2008
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification
- ClinicalTrials.gov ID
- NCT00782743
- Acronym / sponsor ID
- Marcumar-ASS-Study
- Conditions
- Valvular Calcification, Coronary Calcification
- Keywords
- phenprocoumon, anticoagulation, acetylic salicylic acid, Need for new anticoagulation treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with required therapy with either ASS or phenprocoumon
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients not fulfilling the inclusion criteria or with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression of coronary and valvular calcification confirmed by computed tomography
Time frame: 18 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Brandenburg, Prof. principal investigator
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Calcification and Coronary Calcification, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of coronary and valvular calcification confirmed by computed tomography (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.