Pulmonary Embolism Clinical Trial
Official title:
Fondaparinux as Monotherapy for Deep Vein Thrombosis and/or Pulmonary Embolism (Pilot Study)
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Recurrent venous thromboembolism despite anticoagulation with warfarin(Or) 2. Clinically important bleeding complications due to warfarin(Or) 3. Inability to achieve the target INR on warfarin(Or) 4. Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or) 5. Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE and 6. Require at least 90 days of anticoagulation 7. Require anticoagulation for objectively confirmed DVT and/or PE 8. Age greater than 18 years 9. Written informed consent Exclusion Criteria: 1. Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl 2. Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk. 3. Pregnancy 4. Known hypersensitivity to fondaparinux |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | GlaxoSmithKline |
United States,
Büller 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. — View Citation
Büller 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. Erratum in: N Engl J Med. 2004 Jan 22;350(4):423. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan | 90 Days | ||
Primary | Recurrent acute symptomatic PE confirmed by chest CT scan | 90 Days | ||
Primary | 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 | Comparison of Day Zero, 6 week, and Day 90 platelet counts, renal function, hematocrit and transaminase level | 90 Days |
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