Mechanical Heart Valve RecipientsPhase 4ESCAT IIINCT00528671
Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications
A Phase 4 study testing phenprocoumon in people with Mechanical Heart Valve Recipients, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mechanical Heart Valve Recipients
- What is being tested?
- phenprocoumon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,571 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Nov 2013
- Phase
- Phase 4
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical heart valve recipients
Who cannot join
- Contra-indication to phenprocoumon
- Ulcerous disease with bleeding tendency,
- Hypo- or hypercoagulability
- Dementia
- Missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Very Low Dose Oral Anticoagulation on Thromboembolism and Bleeding Events in Patients With Mechanical Heart Valve Replacement
We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.
Read the detailed description
In mechanical heart valve recipients, self-management of oral anticoagulation can reduce the risk of developing thromboembolic events and improves long-term survival compared with international normalized ratio (INR) control by a general practitioner. Low-dose INR self-management (INR values of 1.8.-2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients) does not increase the risk of thromboembolic events compared to conventional dose INR self-management. Even in patients with a low INR target range, however, the risk of bleeding events is still higher than the risk of thromboembolism. We therefore perform a prospective, randomized trial in 1,800 patients with mechanical heart valve replacement. During the first six postoperative months, low dose INR self-management will be performed by all patients (INR measurement once a week). Thereafter, 600 patients will continue with this treatment regimen, whereas the other 1,200 patients with perform very low dose oral anticoagulation. Out of these 1,200 patients, 600 will perform INR measurement once a week and 600 patients will perform INR measurement twice a week. Patients are followed up for 24 months.
- Conditions
- Mechanical Heart Valve Recipients
- Being tested
- phenprocoumon
- Keywords
- phenprocoumon, INR self-management, mechanical heart valve replacement, bleeding, thromboembolism
- Medical subject headings
- Hemorrhage, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenprocoumonDrug
The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.8 - 2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients, INR-self management once a week
phenprocoumonDrug
The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management once a week
phenprocoumonDrug
The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management twice a week
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Low dose oral anticoagulation, INR self-management once a week Receives: Drug: phenprocoumon |
| B | Active comparator | very low dose oral anticoagulation, INR self-management once a week Receives: Drug: phenprocoumon |
| C | Experimental | very low dose oral anticoagulation, INR self-management twice a week Receives: Drug: phenprocoumon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic events, Bleeding events, Survival rates
Measured: 2 years
Secondary outcomes (1)
INR values, Percent of INR values in the target range
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startJan 2006
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mechanical Heart Valve RecipientsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Ludwigshafen, University of Kiel
- Responsible party
- Sponsor
- Investigators
- Heinrich Koertke, MD, Principal investigator, Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528671
- Sponsor's protocol ID
- 002
- Acronym
- ESCAT III
- Status last verified
- Dec 2013
- First submitted
- 11 Sep 2007
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koertke H, Minami K, Boethig D, Breymann T, Seifert D, Wagner O, Atmacha N, Krian A, Ennker J, Taborski U, Klovekorn WP, Moosdorf R, Saggau W, Koerfer R. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation. 2003 Sep 9;108 Suppl 1:II75-8. doi: 10.1161/01.cir.0000089185.80318.3f.
PubMed 12970212Koertke H, Zittermann A, Wagner O, Koerfer R. Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement. Ann Thorac Surg. 2007 Jan;83(1):24-9. doi: 10.1016/j.athoracsur.2006.08.036.
PubMed 17184625Koertke H, Zittermann A, Mommertz S, El-Arousy M, Litmathe J, Koerfer R. The Bad Oeynhausen concept of INR self-management. J Thromb Thrombolysis. 2005 Feb;19(1):25-31. doi: 10.1007/s11239-005-0937-1.
PubMed 15976964Koertke H, Zittermann A, Minami K, Tenderich G, Wagner O, El-Arousy M, Krian A, Ennker J, Taborski U, Klovekorn WP, Moosdorf R, Saggau W, Morshuis M, Koerfer J, Seifert D, Koerfer R. Low-dose international normalized ratio self-management: a promising tool to achieve low complication rates after mechanical heart valve replacement. Ann Thorac Surg. 2005 Jun;79(6):1909-14; discussion 1914. doi: 10.1016/j.athoracsur.2004.09.012.
PubMed 15919283
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Very Low Dose Oral Anticoagulation on Thromboembolism and Bleeding Events in Patients With Mechanical Heart Valve Replacement
- ClinicalTrials.gov ID
- NCT00528671
- Acronym / sponsor ID
- ESCAT III / 002
- Conditions
- Mechanical Heart Valve Recipients
- Keywords
- phenprocoumon, INR self-management, mechanical heart valve replacement, bleeding, thromboembolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,571 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Collaborators
- Klinikum Ludwigshafen, University of Kiel
- Study start
- Jan 2006
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Sep 2007 (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.
We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.
Detailed description
In mechanical heart valve recipients, self-management of oral anticoagulation can reduce the risk of developing thromboembolic events and improves long-term survival compared with international normalized ratio (INR) control by a general practitioner. Low-dose INR self-management (INR values of 1.8.-2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients) does not increase the risk of thromboembolic events compared to conventional dose INR self-management. Even in patients with a low INR target range, however, the risk of bleeding events is still higher than the risk of thromboembolism. We therefore perform a prospective, randomized trial in 1,800 patients with mechanical heart valve replacement. During the first six postoperative months, low dose INR self-management will be performed by all patients (INR measurement once a week). Thereafter, 600 patients will continue with this treatment regimen, whereas the other 1,200 patients with perform very low dose oral anticoagulation. Out of these 1,200 patients, 600 will perform INR measurement once a week and 600 patients will perform INR measurement twice a week. Patients are followed up for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: phenprocoumonLow dose oral anticoagulation, INR self-management once a week |
| B | Active comparator | Drug: phenprocoumonvery low dose oral anticoagulation, INR self-management once a week |
| C | Experimental | Drug: phenprocoumonvery low dose oral anticoagulation, INR self-management twice a week |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanical heart valve recipients
Key exclusion criteria (5 listed)
- Contra-indication to phenprocoumon
- Ulcerous disease with bleeding tendency,
- Hypo- or hypercoagulability
- Dementia
- Missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenprocoumonThe daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.8 - 2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients, INR-self management once a week | Drug | A |
| phenprocoumonThe daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management once a week | Drug | B |
| phenprocoumonThe daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management twice a week | Drug | C |
Primary outcome
Thromboembolic events, Bleeding events, Survival rates
Time frame: 2 years
1 secondary outcome
INR values, Percent of INR values in the target range
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 12970212Koertke H, Minami K, Boethig D, Breymann T, Seifert D, Wagner O, Atmacha N, Krian A, Ennker J, Taborski U, Klovekorn WP, Moosdorf R, Saggau W, Koerfer R. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation. 2003 Sep 9;108 Suppl 1:II75-8. doi: 10.1161/01.cir.0000089185.80318.3f.
- Background: PubMed 17184625Koertke H, Zittermann A, Wagner O, Koerfer R. Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement. Ann Thorac Surg. 2007 Jan;83(1):24-9. doi: 10.1016/j.athoracsur.2006.08.036.
- Background: PubMed 15976964Koertke H, Zittermann A, Mommertz S, El-Arousy M, Litmathe J, Koerfer R. The Bad Oeynhausen concept of INR self-management. J Thromb Thrombolysis. 2005 Feb;19(1):25-31. doi: 10.1007/s11239-005-0937-1.
- Background: PubMed 15919283Koertke H, Zittermann A, Minami K, Tenderich G, Wagner O, El-Arousy M, Krian A, Ennker J, Taborski U, Klovekorn WP, Moosdorf R, Saggau W, Morshuis M, Koerfer J, Seifert D, Koerfer R. Low-dose international normalized ratio self-management: a promising tool to achieve low complication rates after mechanical heart valve replacement. Ann Thorac Surg. 2005 Jun;79(6):1909-14; discussion 1914. doi: 10.1016/j.athoracsur.2004.09.012.
Related trials for Mechanical Heart Valve Recipients
Active, not recruitingPhase 4
Therapeutic Initial Heparin Dosing for Patients With Clots or Certain Heart Conditions Admitted to the Hospital
Pulmonary Embolism, Deep Vein Thrombosis
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.
Heinrich Koertke, MD principal investigator
Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phenprocoumon in people with Mechanical Heart Valve Recipients, run by Heart and Diabetes Center North-Rhine Westfalia 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Dec 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Thromboembolic events, Bleeding events, Survival rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00528671, which also lists 4 linked publications.
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 11 Dec 2013.