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| Name | Class |
|---|---|
| Klinikum Ludwigshafen | OTHER |
| University of Kiel | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Low dose oral anticoagulation, INR self-management once a week |
|
| B | Active Comparator | very low dose oral anticoagulation, INR self-management once a week |
|
| C | Experimental | very low dose oral anticoagulation, INR self-management twice a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenprocoumon | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Thromboembolic events, Bleeding events, Survival rates | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| INR values, Percent of INR values in the target range | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heinrich Koertke, MD | Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Diabetes Center NRW | Bad Oeynhausen | 32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12970212 | Background | 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. | |
| 17184625 |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D010644 | Phenprocoumon |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| phenprocoumon | Drug | 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 |
|
| phenprocoumon | Drug | 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 |
|
| Koertke 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. |
| 15976964 | Background | Koertke 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. |
| 15919283 | Background | Koertke 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. |
| D002318 | Cardiovascular Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |