Deep Vein Thrombosis of Lower LimbPhase 3MORGAGNINCT01285661
Optimal Duration of Anticoagulation in Deep Venous Thrombosis
A Phase 3 study testing Sodium warfarin in people with Deep Vein Thrombosis of Lower Limb and Lower Extremity Deep Venous Thrombosis Recurrent, run by University of Padova at 1 site in Italy.
Trial summary
Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in patients at their first episode of proximal deep venous thrombosis (DVT) of the lower extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal risk factors for thrombosis, with the help of an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis of Lower Limb, Lower Extremity Deep Venous Thrombosis Recurrent
- What is being tested?
- Sodium warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 proximal DVT that is idiopathic or secondary to minor factors for thrombosis, with or without contemporary manifestations of PE, who have completed an uneventful 3 to 24-month period of anticoagulation and are available for an overall 48-month follow-up at the study centre.
Who cannot join
- previous thromboembolism
- recent (less than 3 months) major trauma or surgery
- active cancer
- immobilization resulting from chronic irreversible medical diseases
- need for indefinite anticoagulation for medical reasons other than VTE
- impossibility to attend the follow-up visits or to have D-dimer determinations
Show all 11Show fewer
- already known major thrombophilia: carriage of deficiencies of natural anticoagulants, lupus-like anticoagulants, homozygosis for factor V Leiden or prothrombin mutation, heterozygosis for both abnormalities
- short (less than 1 year) life expectancy
- pregnancy
- age younger than 18
- refusal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Optimal Duration of Anticoagulation in Patients With Deep Venous Thrombosis of the Lower Extremities With the Use of Residual Vein Thrombosis in Combination With D-Dimer
Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in patients at their first episode of proximal deep venous thrombosis (DVT) of the lower extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal risk factors for thrombosis, with the help of an algorithm which incorporates both ultrasonography and D-dimer information. All patients will be followed-up until 1) the achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death; 4) the date of study stop. The purpose of this study is to demonstrate the safety of withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3 months). The approach will be deemed to be safe if the annual rate of recurrent VTE in patients who will have their anticoagulation discontinued is lower than 5%.
Read the detailed description
After giving informed consent, patients will receive an ultrasound investigation of the proximal-vein system (common femoral vein at groin, popliteal vein up to its trifurcation):
- Patients with residual thrombosis (defined as a diameter of at least 4 mm in at least one spot) will have their anticoagulation continued. A repeat ultrasound is scheduled after 6, 12, 18, 24 and 36 months. In patients with persistently residual thrombosis anticoagulation will not be discontinued, while those whose veins have recanalized will have a decision making process based on the behaviour of D-dimer (see below).
- Patients whose veins have recanalized (either at the recruitment or later on) will receive the D-dimer determination before discontinuing anticoagulation. In those with negative D-dimer anticoagulation will be discontinued. These patients will have two further determinations of D-dimer (after 1 and 3 months, respectively). While patients with persistently negative D-dimer will no longer receive anticoagulation, those in whom D-dimer becomes positive will have their anticoagulation resumed and no longer discontinued.
- All patients will be followed up to completion of 4 years since recruitment. For the purpose of this study each quantitative D-dimer is allowed. The criterion for D-dimer interpretation will rely on the cut-off that is recommended by manufacturers for diagnostic purposes.
D-dimer.For the purpose of this study each quantitative D-dimer is allowed. The criterion for D-dimer interpretation will rely on the cut-off that is recommended by manufacturers for diagnostic purposes.
Sample size 1000 years of observation without anticoagulation are required to demonstrate (power 90%, type I error 0.05, two sided) that with this approach the annual rate of recurrent VTE is lower than 5%. Approximately 600 patients with proximal DVT satisfying the eligibility criteria are required to obtain 1000 years of observation without anticoagulation.
- Being tested
- Sodium warfarin
- Keywords
- Deep venous thrombosis, Pulmonary embolism, Ultrasonography, D-dimer, Venous thromboembolism, Bleeding
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium warfarinDrug
Also called Vitamin K antagonists, Oral anticoagulants
Patients with early vein recanalization, as shown by ultrasonography, and repeatedly negative D-dimer will have anticoagulation discontinued. They will be followed-up for up to 4 years after recruitment in order to assess the rate of recurrent symptomatic VTE. In all other patients anticoagulation will not be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Proximal DVT | Experimental | Patients whose veins have recanalized (either at the recruitment or later on during the follow-up) will receive the D-dimer determination before discontinuing sodium warfarin. Veins are defined as recanalized when the vein diameter under maximum compressibility is lower than 4 mm both at the common femoral and at the popliteal vein. In those with negative D-dimer sodium warfarin will be discontinued. These patients will have two further determinations of D-dimer (after 1 and 3 months, respectively). While patients with persistently negative D-dimer will no longer receive sodium warfarin, those in whom D-dimer is positive or reverts to positive values in the following determinations will have their sodium warfarin resumed and no longer discontinued. Receives: Drug: Sodium warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent venous thromboembolism (VTE)
To assess the rate of recurrent symptomatic VTE (expressed as rate/1000 patients-yeas) occurring after discontinuation of oral anticoagulant therapy up to the study conclusion.
Measured: Up to the study conclusion (see the study protocol)
Secondary outcomes (1)
Development of major bleeding complications
To assess the rate of major or clinically relevant bleeding complications (expressed as rate/1000 patients-years) occurring during oral anticoagilant therapy up to the study conclusion
Measured: Up to the study conclusion (see the study protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein Thrombosis of Lower LimbStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Prandoni, Principal investigator, Department of Cardiothoracic and Vascular Sciences, University of Padua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285661
- Sponsor's protocol ID
- 2001P
- Acronym
- MORGAGNI
- Status last verified
- Jul 2016
- First submitted
- 30 Apr 2010
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prandoni P, Vedovetto V, Ciammaichella M, Bucherini E, Corradini S, Enea I, Cosmi B, Mumoli N, Visona A, Barillari G, Bova C, Quintavalla R, Zanatta N, Pedrini S, Villalta S, Camporese G, Testa S, Parisi R, Becattini C, Cuppini S, Pengo V, Palareti G; Morgagni Investigators. Residual vein thrombosis and serial D-dimer for the long-term management of patients with deep venous thrombosis. Thromb Res. 2017 Jun;154:35-41. doi: 10.1016/j.thromres.2017.04.002. Epub 2017 Apr 4.
PubMed 28407492
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Optimal Duration of Anticoagulation in Patients With Deep Venous Thrombosis of the Lower Extremities With the Use of Residual Vein Thrombosis in Combination With D-Dimer
- ClinicalTrials.gov ID
- NCT01285661
- Acronym / sponsor ID
- MORGAGNI / 2001P
- Keywords
- Deep venous thrombosis, Pulmonary embolism, Ultrasonography, D-dimer, Venous thromboembolism, Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in patients at their first episode of proximal deep venous thrombosis (DVT) of the lower extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal risk factors for thrombosis, with the help of an algorithm which incorporates both ultrasonography and D-dimer information. All patients will be followed-up until 1) the achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death; 4) the date of study stop. The purpose of this study is to demonstrate the safety of withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3 months). The approach will be deemed to be safe if the annual rate of recurrent VTE in patients who will have their anticoagulation discontinued is lower than 5%.
Detailed description
After giving informed consent, patients will receive an ultrasound investigation of the proximal-vein system (common femoral vein at groin, popliteal vein up to its trifurcation):
- Patients with residual thrombosis (defined as a diameter of at least 4 mm in at least one spot) will have their anticoagulation continued. A repeat ultrasound is scheduled after 6, 12, 18, 24 and 36 months. In patients with persistently residual thrombosis anticoagulation will not be discontinued, while those whose veins have recanalized will have a decision making process based on the behaviour of D-dimer (see below).
- Patients whose veins have recanalized (either at the recruitment or later on) will receive the D-dimer determination before discontinuing anticoagulation. In those with negative D-dimer anticoagulation will be discontinued. These patients will have two further determinations of D-dimer (after 1 and 3 months, respectively). While patients with persistently negative D-dimer will no longer receive anticoagulation, those in whom D-dimer becomes positive will have their anticoagulation resumed and no longer discontinued.
- All patients will be followed up to completion of 4 years since recruitment. For the purpose of this study each quantitative D-dimer is allowed. The criterion for D-dimer interpretation will rely on the cut-off that is recommended by manufacturers for diagnostic purposes.
D-dimer.For the purpose of this study each quantitative D-dimer is allowed. The criterion for D-dimer interpretation will rely on the cut-off that is recommended by manufacturers for diagnostic purposes.
Sample size 1000 years of observation without anticoagulation are required to demonstrate (power 90%, type I error 0.05, two sided) that with this approach the annual rate of recurrent VTE is lower than 5%. Approximately 600 patients with proximal DVT satisfying the eligibility criteria are required to obtain 1000 years of observation without anticoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal DVT | Experimental | Drug: Sodium warfarinPatients whose veins have recanalized (either at the recruitment or later on during the follow-up) will receive the D-dimer determination before discontinuing sodium warfarin. Veins are defined as recanalized when the vein diameter under maximum compressibility is lower than 4 mm both at the common femoral and at the popliteal vein. In those with negative D-dimer sodium warfarin will be discontinued. These patients will have two further determinations of D-dimer (after 1 and 3 months, respectively). While patients with persistently negative D-dimer will no longer receive sodium warfarin, those in whom D-dimer is positive or reverts to positive values in the following determinations will have their sodium warfarin resumed and no longer discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with proximal DVT that is idiopathic or secondary to minor factors for thrombosis, with or without contemporary manifestations of PE, who have completed an uneventful 3 to 24-month period of anticoagulation and are available for an overall 48-month follow-up at the study centre.
Key exclusion criteria (11 listed)
- previous thromboembolism
- recent (less than 3 months) major trauma or surgery
- active cancer
- immobilization resulting from chronic irreversible medical diseases
- need for indefinite anticoagulation for medical reasons other than 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 |
|---|---|---|
| Sodium warfarinAlso: Vitamin K antagonists, Oral anticoagulantsPatients with early vein recanalization, as shown by ultrasonography, and repeatedly negative D-dimer will have anticoagulation discontinued. They will be followed-up for up to 4 years after recruitment in order to assess the rate of recurrent symptomatic VTE. In all other patients anticoagulation will not be discontinued. | Drug | Proximal DVT |
Primary outcome
Recurrent venous thromboembolism (VTE)
Time frame: Up to the study conclusion (see the study protocol)
To assess the rate of recurrent symptomatic VTE (expressed as rate/1000 patients-yeas) occurring after discontinuation of oral anticoagulant therapy up to the study conclusion.
1 secondary outcome
Development of major bleeding complications
Time frame: Up to the study conclusion (see the study protocol)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Derived from this study: PubMed 28407492Prandoni P, Vedovetto V, Ciammaichella M, Bucherini E, Corradini S, Enea I, Cosmi B, Mumoli N, Visona A, Barillari G, Bova C, Quintavalla R, Zanatta N, Pedrini S, Villalta S, Camporese G, Testa S, Parisi R, Becattini C, Cuppini S, Pengo V, Palareti G; Morgagni Investigators. Residual vein thrombosis and serial D-dimer for the long-term management of patients with deep venous thrombosis. Thromb Res. 2017 Jun;154:35-41. doi: 10.1016/j.thromres.2017.04.002. Epub 2017 Apr 4.
Related trials for Deep Vein Thrombosis of Lower Limb
RecruitingObservational study
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature
RecruitingObservational study
TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization
Lower Extremity Injuries, Venous Thromboembolism (VTE)
RecruitingObservational study
Predictive Value of Modified Caprini Score and D-Dimer in Managing Lower Limb Venous Thrombosis in Cardiothoracic Patients
DVT - Deep Vein Thrombosis
Active, not recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
Venous Thromboses, Venous Disease
Recruiting
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Vascular, DVT - Deep Vein Thrombosis
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.
Paolo Prandoni principal investigator
Department of Cardiothoracic and Vascular Sciences, University of Padua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium warfarin in people with Deep Vein Thrombosis of Lower Limb and Lower Extremity Deep Venous Thrombosis Recurrent, run by University of Padova 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 19 Jul 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 venous thromboembolism (VTE) (time frame: Up to the study conclusion (see the study protocol)). 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 NCT01285661, which also lists 1 linked publication.
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 19 Jul 2016.