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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
German Research Foundation
German Federal Ministry of Education and Research
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00895505
First received: May 7, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Deep Venous Thrombosis
Drug: Phenprocoumon
Drug: Warfarin-Natrium
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
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)
Arms Assigned Interventions
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.
Drug: Phenprocoumon
Phenprocoumon 3 mg, tablet, INR adjusted
Drug: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895505

Contacts
Contact: Bernd Poetzsch, Professor +49-228-28716745 bernd.poetzsch@ukb.uni-bonn.de

Locations
Germany
Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
Contact: Bernd Poetzsch, Professor       bernd.poetzsch@ukb.uni-bonn.de   
Principal Investigator: Bernd Poetzsch, Professor         
Sponsors and Collaborators
University Hospital, Bonn
German Research Foundation
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Bernd Poetzsch, Professor Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
  More Information

No publications provided

Responsible Party: Prof. Dr. Bernd Pötzsch, Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
ClinicalTrials.gov Identifier: NCT00895505     History of Changes
Other Study ID Numbers: DDOAT2006
Study First Received: May 7, 2009
Last Updated: May 7, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Bonn:
DVT
Venous thromboembolism
D-Dimer
thrombophilia
secondary prophylaxis
secondary prophylaxis using oral anticoagulant treatment (OAT)
higher risk of recurrence in patients showing increased levels
of D-Dimer after withdrawal of OAT
D-Dimer-based treatment

Additional relevant MeSH terms:
Anticoagulants
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Fibrin fragment D
Phenprocoumon
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014