Venous ThromboembolismNCT00428441
D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism
A study testing Warfarin in people with Venous Thromboembolism, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 73 participants
- Where
- 1 siteItaly
- Study dates
- May 2007to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism)
- Ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic DVT was the last event; b) 6 months in all other cases
- Age > 18 years
- Informed consent provided
Who cannot join
- Pregnancy/puerperium
- One or more episodes of massive pulmonary embolism
- Last event isolated idiopathic pulmonary embolism
- Two or more idiopathic VTE events
- First degree relatives with recurrent VTE
- Right ventricular disfunction or pulmonary hypertension
Show all 17Show fewer
- Active cancer
- Antiphospholipid antibodies syndrome
- Antithrombin deficiency
- Homozygous Factor V Leiden or G20210A prothrombin mutation
- Heterozygous Factor V Leiden and G20210A prothrombin mutation
- Concomitant congenital thrombophilic mutations
- Concomitant indications to long term oral anticoagulant treatment
- Severe cardiorespiratory insufficiency
- Severe liver or renal disease (creatinine clearance > 2 mg/dL)
- Limited life expectancy
- Geographic inaccessibility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Negative Predictive Value of D-dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study
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.
- Conditions
- Venous Thromboembolism
- Being tested
- Warfarin
- Keywords
- D-dimer, Recurrence, Venous thromboembolism
- Medical subject headings
- Venous Thromboembolism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
tablets, based on INR levels, according to D-dimer levels
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations
Measured: 3 months
Secondary outcomes (3)
Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy
Measured: 3 months
Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy
Measured: 3 months
Mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2010
- Study completionMay 2011
Why it stopped: Enrolment was halted prematurely because of the observed excess in recurrences
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Ageno, Università degli Studi dell'Insubria
- Investigators
- Gualtiero Palareti, Study chair, University of BolognaWalter Ageno, Study director, Università degli Studi dell'InsubriaVittorio Pengo, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428441
- Sponsor's protocol ID
- 2175
- Status last verified
- Aug 2011
- First submitted
- 26 Jan 2007
- Last updated
- 26 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17065639Palareti 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.
PubMed 11848459
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Negative Predictive Value of D-dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00428441
- Acronym / sponsor ID
- 2175
- Conditions
- Venous Thromboembolism
- Keywords
- D-dimer, Recurrence, Venous thromboembolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolment was halted prematurely because of the observed excess in recurrences
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 30 Jan 2007 (estimated)
- Results
- Posted 26 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism)
- Ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic DVT was the last event; b) 6 months in all other cases
- Age > 18 years
- Informed consent provided
Key exclusion criteria (17 listed)
- Pregnancy/puerperium
- One or more episodes of massive pulmonary embolism
- Last event isolated idiopathic pulmonary embolism
- Two or more idiopathic VTE events
- First degree relatives with recurrent VTE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarintablets, based on INR levels, according to D-dimer levels | Drug | – |
Primary outcome
Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels
Time frame: 1 year
Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis
Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations
Time frame: 3 months
3 secondary outcomes
Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy
Time frame: 3 months
Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy
Time frame: 3 months
Mortality
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17065639Palareti 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.
- Background: PubMed 11848459Palareti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gualtiero Palareti study chair
University of Bologna
Walter Ageno study director
Università degli Studi dell'Insubria
Vittorio Pengo study director
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin in people with Venous Thromboembolism, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00428441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011.