D-Dimer Guided Oral Anticoagulant Treatment (OAT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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oral anticoagulants

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

Group Type ACTIVE_COMPARATOR

Phenprocoumon

Intervention Type DRUG

Phenprocoumon 3 mg, tablet, INR adjusted

Warfarin-Natrium

Intervention Type DRUG

Warfarin-Natrium 5 mg, tablet, INR adjusted

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Phenprocoumon

Phenprocoumon 3 mg, tablet, INR adjusted

Intervention Type DRUG

Warfarin-Natrium

Warfarin-Natrium 5 mg, tablet, INR adjusted

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No