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Enrolment was halted prematurely because of the observed excess in recurrences
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Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low.
The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels.
Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | tablets, based on INR levels, according to D-dimer levels |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels | Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis | 1 year |
| Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy | 3 months | |
| Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gualtiero Palareti | University of Bologna | Study Chair |
| Walter Ageno | Università degli Studi dell'Insubria | Study Director |
| Vittorio Pengo | University of Padova | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Insubria | Varese | 21100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17065639 | Background | Palareti G, Cosmi B, Legnani C, Tosetto A, Brusi C, Iorio A, Pengo V, Ghirarduzzi A, Pattacini C, Testa S, Lensing AW, Tripodi A; PROLONG Investigators. D-dimer testing to determine the duration of anticoagulation therapy. N Engl J Med. 2006 Oct 26;355(17):1780-9. doi: 10.1056/NEJMoa054444. | |
| 11848459 | Background |
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recruitment period 2007-2009 location Thrombosis centers
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| ID | Title | Description |
|---|---|---|
| FG000 | D-dimer Negative | patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | D-dimer Negative | patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels | Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis | Posted | Number | participants | 1 year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-dimer Negative | patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Walter Ageno | University of Insubria | +39 0332 278831 | agewal@yahoo.com |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Mortality | 3 months |
| Palareti G, Legnani C, Cosmi B, Guazzaloca G, Pancani C, Coccheri S. Risk of venous thromboembolism recurrence: high negative predictive value of D-dimer performed after oral anticoagulation is stopped. Thromb Haemost. 2002 Jan;87(1):7-12. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations | Not Posted | 3 months |
| Secondary | Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy | Not Posted | 3 months |
| Secondary | Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy | Not Posted | 3 months |
| Secondary | Mortality | Not Posted | 3 months |
| 0 |
| 75 |
| 0 |
| 75 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |