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

May 7, 2009 updated by: University Hospital, Bonn

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
        • Recruiting
        • Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
        • Contact:
        • Principal Investigator:
          • Bernd Poetzsch, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Time Frame: Duration of intervention per patient (24 months)
Duration of intervention per patient (24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Duration of intervention per patient (24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Collaborators

German Research Foundation
German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Bernd Poetzsch, Professor, Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

May 7, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (Estimate)

May 8, 2009

Study Record Updates

Last Update Posted (Estimate)

May 8, 2009

Last Update Submitted That Met QC Criteria

May 7, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDOAT2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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