Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Twinkle Singh, M.B.B.S. [2]
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
Objective
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.
Sponsor
University Hospital, Bonn
Timeline
| Timeline | |
| Start Date | February 2008 |
| End Date | February 2012 |
| Status | Unknown |
The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00895505.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | |
| Allocation | Randomized |
| Endpoint | Safety/Efficacy Study |
| Interventional Model | Parallel Assignment |
| Masking | Open Label |
| Study Details | |
| Primary Purpose | |
| Condition | Deep Venous Thrombosis |
| Intervention | Phenprocoumon 3 mg, tablet, INR adjusted Warfarin-Natrium 5 mg, tablet, INR adjusted |
| Study Arms | Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis Control: Withdrawal of OAT in VTE patients after end of routine secondary prophylaxis and receiving low molecular weight heparin in risk situations |
| Population Size | 300 |
The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00895505.
Eligibility 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 (Oral Anticoagulant Therapy) (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
Outcomes
Primary Outcomes
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 Outcomes
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 ]