Optimal Duration of Anticoagulation in Deep Venous Thrombosis

NCT01285661 | Completed Phase 3 DMC

• 1 other identifier: 2001P
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

Brief 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 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%.

Conditions

Deep Vein Thrombosis of Lower Limb; Lower Extremity Deep Venous Thrombosis Recurrent

Keywords

Deep venous thrombosis; Pulmonary embolism; Ultrasonography; D-dimer; Venous thromboembolism; Bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to the study conclusion (see the study protocol)

Secondary Outcomes (1)

• Development of major bleeding complications

  Up to the study conclusion (see the study protocol)

Study Arms (1)

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.

Drug: Sodium warfarin

Interventions

Sodium warfarin DRUG

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.

Also known as: Vitamin K antagonists, Oral anticoagulants

Proximal DVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Paolo Prandoni

Padua, 35028, Italy

Location

Related Publications (1)

• 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.

  PMID: 28407492 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism; Hemorrhage

Interventions

Vitamin B 6; acarboxyprothrombin; Anticoagulants

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thromboembolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Paolo Prandoni

  Department of Cardiothoracic and Vascular Sciences, University of Padua

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: January 28, 2011
• Study Start: March 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

IT (1)