Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial: Difference between revisions
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==Official Title== | ==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== | ==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== | ==Sponsor== | ||
University Hospital, Bonn | |||
==Timeline== | ==Timeline== | ||
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%" | {| class="wikitable" border="1" style="background:WhiteSmoke" width="40%" | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Timeline''' | ||
|- | |- | ||
| Style="width:30%"| '''Start Date'''||Style="width:70%"| | | Style="width:30%"| '''Start Date'''||Style="width:70%"| February 2008 | ||
|- | |- | ||
| ''' | | '''End Date'''||February 2012 | ||
|- | |- | ||
| '''Status'''||Unknown | |||
| '''Status'''|| | |||
|- | |- | ||
|} | |} | ||
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number | <span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00895505.</span> | ||
==Study Description== | ==Study Description== | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | ||
|- | |- | ||
| Style="width:30%"|'''Study Type'''|| Style="width:70%"| | | Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional | ||
|- | |- | ||
| '''Study Phase''' || | | '''Study Phase''' ||Phase 3 | ||
|- | |- | ||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | ||
|- | |- | ||
| '''Allocation'''|| | | '''Allocation'''||Randomized | ||
|- | |- | ||
| '''Endpoint'''|| | | '''Endpoint'''||Safety/Efficacy Study | ||
|- | |- | ||
| '''Interventional Model'''|| | | '''Interventional Model'''||Parallel Assignment | ||
|- | |- | ||
| '''Masking'''|| | | '''Masking'''|| Open Label | ||
|- | |- | ||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | ||
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| '''Primary Purpose'''|| | | '''Primary Purpose'''|| | ||
|- | |- | ||
| '''Condition'''|| | | '''Condition'''||Deep Venous Thrombosis | ||
|- | |- | ||
| '''Intervention'''|| | | '''Intervention'''||Phenprocoumon 3 mg, tablet, INR adjusted<br>Warfarin-Natrium 5 mg, tablet, INR adjusted | ||
|- | |- | ||
| '''Study Arms'''|| | | '''Study Arms'''||Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis<br>Control: Withdrawal of OAT in VTE patients after end of routine secondary prophylaxis and receiving low molecular weight heparin in risk situations | ||
|- | |- | ||
| '''Population Size'''|| | | '''Population Size'''||300 | ||
|- | |- | ||
|} | |} | ||
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number | <span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00895505.</span> | ||
==Eligibility Criteria== | ==Eligibility Criteria== | ||
===Inclusion 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=== | ===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== | ==Outcomes== | ||
===Primary 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=== | ===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 ] | |||
==Publications== | ==Publications== | ||
===Results=== | ===Results=== |
Latest revision as of 21:40, 25 September 2013
D-Dimer Microchapters |
Clinical Correlation |
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Clinical Trials |
Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial On the Web |
American Roentgen Ray Society Images of Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial |
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 ]