D-dimer to Establish Duration of Anticoagulation After Ve... | NCT00264277

Studies
D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism

NCT00264277

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Completed

Last Update Posted

Mar 19, 2021Actual

Enrollment

600

Phase

Phase 4

Conditions

Deep Vein Thrombosis
Pulmonary Embolism

Interventions

Vitamin K antagonist (Coumarin anticoagulants)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Dec 2004Actual

Completion Date

Sep 2005Actual

First Submitted Date

Dec 9, 2005

First Submission Date that Met QC Criteria

Dec 9, 2005

First Posted Date

Dec 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2021

Last Update Posted Date

Mar 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GUALTIERO PALARETI, Professor, IRCCS Azienda Ospedaliero-Universitaria di BolognaPrincipal Investigator

Lead Sponsor

IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER

Collaborators

Not provided

Description Module

Brief Summary

The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients

Detailed Description

This is a multicenter prospective follow-up study in patients with a first episode of symptomatic idiopathic venous thromboembolism (proximal deep vein thrombosis and/or pulmonary embolism) who are treated with vitamin K antagonists (either warfarin or acenocoumarol) for a minimum of 3 months. Eligible patients who give informed consent are instructed to immediately stop oral anticoagulation and refrain from taking any other antithrombotic drugs until the next visit, scheduled after 30 days. At that visit, venous blood is sampled to perform D-dimer assay and thrombophilia tests. D-dimers are assessed using the Clearview Simplify D-dimer assay (Agen Biomedical Limited, Brisbane, Australia). Patients with normal D-dimer results do not continue anticoagulation, whereas those with elevated D-dimer results are randomized using a computer program to either stop or resume anticoagulation with vitamin K antagonists (INR 2.0-3.0). All patients are followed-up for 18 months. The study outcome are the composite of confirmed recurrent venous thromboembolism and major bleeding events. All suspected outcome events and all deaths are evaluated by a central adjudication committee whose members are unaware of the D-dimer and thrombophilia results and of the group assignments.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600

Name	Type	Description	Arm Group Labels	Other Names
Vitamin K antagonist (Coumarin anticoagulants)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up
Confirmed major bleeding events at 18 months follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
After at least 3 months of oral anticoagulation
After written informed consent

Exclusion Criteria:

If the Venous thromboembolism occurred:
during pregnancy or puerperium
after recent (i.e. within three months) fracture or plaster casting of a leg,
after immobilization with confinement to bed for three consecutive days
after surgery with general anesthesia lasting longer than 30 minutes
Patients with:
active cancer
antiphospholipid antibody syndrome
antithrombin deficiency
serious liver disease or renal insufficiency (creatininemia > 2 mg/dL),
other indications for anticoagulation or contraindications for this treatment
limited life expectation
Patients who live too far from the clinical center

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GUALTIERO PALARETI, MD	Head of Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi		Bologna	BO	40138	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11848459	Background	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.
12847064	Background	Palareti G, Legnani C, Cosmi B, Valdre L, Lunghi B, Bernardi F, Coccheri S. Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia. Circulation. 2003 Jul 22;108(3):313-8. doi: 10.1161/01.CIR.0000079162.69615.0F. Epub 2003 Jul 7.

ID	Term
D020246	Venous Thrombosis
D011655	Pulmonary Embolism
D012008	Recurrence
D054556	Venous Thromboembolism

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases