Please select the eligibility criteria that correspond to the clinical trial below.
Title: The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
Brief Summary: This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.

The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.

Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.


Options:
A: 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
B: Inclusion criteria:

* Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.

Exclusion criteria:

* Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
* deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,
* anticoagulant medication for more than 48 hours prior to inclusion,
* need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,
* major surgery within last 3 months, low platelet count (below 100×109/L),
* kidney disease (Calculated creatinine clearance \< 30 mL/min), woman of child-bearing potential not using reliable contraceptive method
C: Inclusion Criteria:

1. Planned for elective arthroplasty for knee and hip disease.
2. Over 20 years of age.
3. Normal baseline platelet count, prothrombin and partial thromboplastin times.
4. Signed consent.

Exclusion Criteria:

1. Surgery for acute fracture (\< 4 weeks), septic joint, or extraction arthroplasty.
2. Patients with personal history of TED, or documented hypercoagulation disease.
3. Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
4. Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
5. Liver enzymes or bilirubin greater than 2 x normal.
6. Decreased renal function with GFR \< 30ml/min. (24-27)
7. Cancer in last 1 year, other than localized cancers of the skin.
8. Requires chronic anticoagulation with warfarin or heparins.
9. Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..
10. Prior adverse reaction to any of the study drugs.
11. Pregnancy
12. Uncontrolled hypertension
D: 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

Answer: A