Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00413504
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00413504
Study Brief:
Protocol Section:
NCT00413504