NCT00413504

Brief Summary

To determine whether fondaparinux as monotherapy without warfarin is effective and safe for long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and data using fondaparinux.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

First QC Date

December 7, 2006

Last Update Submit

February 2, 2009

Conditions

Deep Vein ThrombosisPulmonary Embolism

Keywords

FondaparinuxMonotherapyDeep Vein thrombosisPulmonary EmbolismAnticoagulation

Outcome Measures

Primary Outcomes (3)

  • Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan

    90 Days

  • Recurrent acute symptomatic PE confirmed by chest CT scan

    90 Days

  • Major hemorrhage defined as spinal, retroperitoneal or intracranial bleeding, drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding

    90 Days

Secondary Outcomes (1)

  • Comparison of Day Zero, 6 week, and Day 90 platelet counts, renal function, hematocrit and transaminase level

    90 Days

Interventions

FondaparinuxDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent venous thromboembolism despite anticoagulation with warfarin(Or)
  • Clinically important bleeding complications due to warfarin(Or)
  • Inability to achieve the target INR on warfarin(Or)
  • Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or)
  • Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE
  • and
  • Require at least 90 days of anticoagulation
  • Require anticoagulation for objectively confirmed DVT and/or PE
  • Age greater than 18 years
  • Written informed consent

You may not qualify if:

  • Patients with renal insufficiency, defined as creatinine \> 1.5 mg/dl
  • Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk.
  • Pregnancy
  • Known hypersensitivity to fondaparinux

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Petitou M, Duchaussoy P, Herbert JM, Duc G, El Hajji M, Branellec JF, Donat F, Necciari J, Cariou R, Bouthier J, Garrigou E. The synthetic pentasaccharide fondaparinux: first in the class of antithrombotic agents that selectively inhibit coagulation factor Xa. Semin Thromb Hemost. 2002 Aug;28(4):393-402. doi: 10.1055/s-2002-34309.

    PMID: 12244487BACKGROUND

  • Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003 Oct 30;349(18):1695-702. doi: 10.1056/NEJMoa035451.

    PMID: 14585937BACKGROUND

  • Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med. 2004 Jun 1;140(11):867-73. doi: 10.7326/0003-4819-140-11-200406010-00007.

    PMID: 15172900BACKGROUND

Related Links

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Samuel Z. Goldhaber, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 19, 2006

Study Start

April 1, 2006

Study Completion

July 1, 2007

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

US(1)