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D-Dimer Guided Oral Anticoagulant Treatment (OAT) (DDOAT2006)

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ClinicalTrials.gov Identifier: NCT00895505
Recruitment Status : Unknown
Verified May 2009 by University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : May 8, 2009
Last Update Posted : May 8, 2009
Sponsor:
Collaborators:
German Research Foundation
German Federal Ministry of Education and Research
Information provided by:
University Hospital, Bonn

May 7, 2009
May 8, 2009
May 8, 2009
February 2008
February 2012   (Final data collection date for primary outcome measure)
Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE) [ Time Frame: Duration of intervention per patient (24 months) ]
Same as current
No Changes Posted
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) ]
Same as current
Not Provided
Not Provided
 
D-Dimer Guided Oral Anticoagulant Treatment (OAT)
Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Deep Venous Thrombosis
  • Drug: Phenprocoumon
    Phenprocoumon 3 mg, tablet, INR adjusted
  • Drug: Warfarin-Natrium
    Warfarin-Natrium 5 mg, tablet, INR adjusted
  • 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.
    Interventions:
    • Drug: Phenprocoumon
    • Drug: Warfarin-Natrium
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
Same as current
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

To be enrolled in this study, patients must:

  • have an objectively confirmed first episode of unprovoked VTE or of VTE during a minor transient risk factor. Minor transient risk factors include 6 weeks of estrogen therapy, prolonged air travel (i.e., > 6 hours), pregnancy, less marked leg injuries or immobilization without injury or surgical intervention
  • be scheduled to receive oral anticoagulant treatment for at least 3 months
  • be willing to be randomized
  • be willing to participate for the full duration of the study

Exclusion Criteria:

  • pregnancy or breast feeding
  • contraindications against OAT (i.e., intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke)
  • age < 18 years
  • presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i.e., antithrombin deficiency, hereditary PC deficiency)
  • poor patient compliance
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00895505
DDOAT2006
Yes
Not Provided
Not Provided
Prof. Dr. Bernd Pötzsch, Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
University Hospital, Bonn
  • German Research Foundation
  • German Federal Ministry of Education and Research
Principal Investigator: Bernd Poetzsch, Professor Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
University Hospital, Bonn
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP