D-Dimer Guided Oral Anticoagulant Treatment (OAT) (DDOAT2006)
Recruitment status was Recruiting
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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 |
- 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 ]
| 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 |
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| Contact: Bernd Poetzsch, Professor | +49-228-28716745 | bernd.poetzsch@ukb.uni-bonn.de |
| 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 | |
| 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 Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Phenprocoumon Warfarin |
Fibrin fragment D Hematologic Agents Therapeutic Uses Pharmacologic Actions Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |
ClinicalTrials.gov processed this record on May 23, 2013