NCT00528671 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Koertke H, Minami K, Boethig D, Breymann T, Seifert D, Wagner O, Atmacha N, Krian A, Ennker J, Taborski U, Klövekorn 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.
Koertke H, Zittermann A, Minami K, Tenderich G, Wagner O, El-Arousy M, Krian A, Ennker J, Taborski U, Klövekorn 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.
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.
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.

Effects of Very Low Dose Oral Anticoagulation on Thromboembolism and Bleeding Events in Patients With Mechanical Heart Valve Replacement

Clinical trial NCT00528671 - References