Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency
Brief Summary: Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.


Options:
A: Inclusion Criteria:

* Non valvular atrial fibrillation (AF)
* Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age \> or = 75 years, diabetes mellitus.

Main exclusion Criteria:

* Indication for VKA other than AF
* Stroke or TIA within previous 5 days
* Transient AF caused by a reversible disorder
* Planned major surgery/trauma or cardioversion within 30 days
* INR \> 3 at baseline
* Active bleeding or high risk of bleeding
* Uncontrolled hypertension
* Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.
B: Inclusion Criteria:

* Age \> 60 years
* Acute medical disease requiring thromboprophylaxis according to international guidelines
* Anticipated immobilization of at least 4 days
* Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
* Written informed consent

Exclusion Criteria:

* Active bleeding or bleeding in the previous 3 months
* Known bleeding diathesis
* Platelet count \< 100.000
* Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
* Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
* Life expectancy \< 1 month
C: Inclusion Criteria:

* ECG-documented atrial fibrillation (AF) and an indication for long-term vitamin K antagonist (VKA) therapy based on the presence of at least one of the following risk factors:

  1. previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism
  2. hypertension requiring drug treatment
  3. left ventricular dysfunction (left ventricular ejection fraction \<45% or symptomatic congestive heart failure)
  4. age \>75 years
  5. age between 65-75 years plus diabetes mellitus, or
  6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris)
* Written informed consent

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
* Transient AF caused by a reversible disorder
* Active bleeding or high risk of bleeding
* Recent (\<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \<10 mL/min, severe hepatic disease, or bacterial endocarditis
* Uncontrolled hypertension: systolic blood pressure \> 180 mm Hg and/or diastolic blood pressure \> 110 mm Hg
* Pregnancy or childbearing potential without proper contraceptive measures
* Breastfeeding
* Any other contraindication listed in the labeling of warfarin or acenocoumarol
D: Inclusion Criteria:

* Confirmed acute symptomatic DVT of the lower limbs

Exclusion Criteria:

* Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension)
* Active bleeding or high risk for bleeding.
* Pregnancy or childbearing potential without proper contraceptive measures.
* Breastfeeding
* Known allergy to idraparinux, SSR126517E, or egg proteins
* Indication of prolonged anticoagulation for other reason than DVT of the lower limbs
* Symptomatic pulmonary embolism (PE)
* Life expectancy \< 6 months.

Answer: B