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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Revision as of 21:39, 25 September 2013

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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 ]

Publications

Results

Conclusion

References

Template:WH Template:WS

@@ Line 5: / Line 5: @@
 ==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==
 {| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
@@ Line 17: / Line 17: @@
 | 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
 |-
-| '''Run-In Period'''||
+| '''End Date'''||February 2012
 |-
-| '''End Date'''||
+| '''Status'''||Unknown
-|-
-| '''Status'''||
 |-
 |}
-<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT------.</span>
+<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==
@@ Line 34: / Line 32: @@
 | 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'''
 |-
-| '''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'''
@@ Line 52: / Line 50: @@
 | '''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 NCT-----.</span>
+<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==
 ===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 ]
 ==Publications==
 ===Results===