D-Dimer Guided Oral Anticoagulant Treatment (OAT)

NCT00895505 | Unknown Phase 3 DMC

• 1 other identifier: DDOAT2006
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep Venous Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE)

  Duration of intervention per patient (24 months)

Secondary Outcomes (1)

• 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)

Study Arms (2)

oral anticoagulants

ACTIVE COMPARATOR

Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis.

Drug: Phenprocoumon; Drug: Warfarin-Natrium

2

NO INTERVENTION

Control: Withdrawal of OAT in VTE patients after end of routine secondary prophylaxis and receiving low molecular weight heparin in risk situations.

Interventions

Phenprocoumon DRUG

Phenprocoumon 3 mg, tablet, INR adjusted

oral anticoagulants

Warfarin-Natrium DRUG

Warfarin-Natrium 5 mg, tablet, INR adjusted

oral anticoagulants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead
• German Research Foundation: collaborator
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism; Thrombophilia

Interventions

Phenprocoumon

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bernd Poetzsch, Professor

  Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernd Poetzsch, Professor

CONTACT

+49-228-28716745; bernd.poetzsch@ukb.uni-bonn.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: February 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 8, 2009

Record last verified: 2009-05

Locations

DE (1)