D-Dimer Guided Oral Anticoagulant Treatment (OAT)

Deep Venous Thrombosis Clinical Trial

— DDOAT2006  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00895505
• Other study ID #: DDOAT2006
• Status: Recruiting
• Phase: Phase 3
• First received: May 7, 2009
• Last updated: May 7, 2009
• Start date: February 2008
• Est. completion date: February 2012

Study information

• Verified date: May 2009
• Source: University Hospital, Bonn
• Contact: Bernd Poetzsch, Professor
• Phone: +49-228-28716745
• Email: bernd.poetzsch[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Phenprocoumon
Phenprocoumon 3 mg, tablet, INR adjusted
• Warfarin-Natrium
Warfarin-Natrium 5 mg, tablet, INR adjusted

Locations

Country	Name	City	State
Germany	Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn	Bonn	Nordrhein-Westfalen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bonn	German Federal Ministry of Education and Research, German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE)		Duration of intervention per patient (24 months)	Yes
Secondary	Incidence and severity of signs and symptoms associated with OAT-induced bleeding measured using the World Health Organization (WHO) bleeding scale.		Duration of intervention per patient (24 months)	Yes