D-Dimer Guided Oral Anticoagulant Treatment (OAT) (DDOAT2006)
Recruitment status was Recruiting
This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous thrombosis (DVT) using a prospective, randomized, and controlled design.
Deep Venous Thrombosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial|
- Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE) [ Time Frame: Duration of intervention per patient (24 months) ] [ Designated as safety issue: Yes ]
- Incidence and severity of signs and symptoms associated with OAT-induced bleeding measured using the World Health Organization (WHO) bleeding scale. [ Time Frame: Duration of intervention per patient (24 months) ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Active Comparator: oral anticoagulants
Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis.
Phenprocoumon 3 mg, tablet, INR adjustedDrug: Warfarin-Natrium
Warfarin-Natrium 5 mg, tablet, INR adjusted
No Intervention: 2
Control: Withdrawal of OAT in VTE patients after end of routine secondary prophylaxis and receiving low molecular weight heparin in risk situations.
After a first episode of acute deep venous thrombosis (DVT) the risk of recurrence is relatively high and clinical consequences are important. Therefore, secondary prophylaxis using oral anticoagulant treatment (OAT) is usually established in these patients. This treatment very effectively reduces the risk of recurrences but induces an increased risk of bleeding. Major bleeding complications can be expected in ~2% patient-years. Therefore, current recommendations limit OAT to a period of 3 to 12 months. After stopping of OAT, however, ~10 % of patients with an initial episode of unprovoked DVT will develop a recurrent event within 1 year. This group of patients may benefit from prolonged OAT. The results of 2 independent observational studies showed a significantly higher risk of recurrence in patients showing increased levels of D-Dimer after withdrawal of OAT. D-Dimer is a biomarker that indicates fibrin formation followed by fibrinolysis. Based on these data we hypothesize that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of DVT. This clinical trial will investigate this hypothesis using a prospective, randomized, and controlled design.
|Contact: Bernd Poetzsch, Professorfirstname.lastname@example.org|
|Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn||Recruiting|
|Bonn, Nordrhein-Westfalen, Germany, 53105|
|Contact: Bernd Poetzsch, Professor email@example.com|
|Principal Investigator: Bernd Poetzsch, Professor|
|Principal Investigator:||Bernd Poetzsch, Professor||Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn|