Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
Brief Summary: The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.


Options:
A: Inclusion Criteria:

* Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.
* Evidence of high risk of vascular events: at least one of the following risk criteria must be present:

  * are 75 years or greater;
  * on treatment for systemic hypertension;
  * prior stroke, TIA, or non-CNS systemic embolus;
  * left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be \< 45%;
  * peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio \< 0.9);
  * age 55 to 74 years; AND
  * either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.

Exclusion Criteria:

* Patients will be excluded from ACTIVE if any of the following are present :

  * requirement for clopidogrel (such as recent coronary stent procedure);
  * requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
  * prior intolerance to ASA or clopidogrel;
  * documented peptic ulcer disease within the previous 6 months;
  * prior intracerebral hemorrhage;
  * significant thrombocytopenia; (platelet count \< 50 x 10(9)/L);
  * psychosocial reason making study participation impractical;
  * geographic reason making study participation impractical;
  * ongoing alcohol abuse;
  * mitral stenosis;
  * pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study;
  * severe comorbid condition such that the patient is not expected to survive 6 months;
  * patient currently receiving an investigational pharmacologic agent; OR
  * requirement for chronic (\> 3 months) non-COX-2 inhibitor NSAID therapy.
B: Inclusion criteria:

* patients between 18 and 85 years
* due to undergo elective PCI
* informed consent obtained

Exclusion criteria:

* PCI lesion specific conditions
* class III or IV congestive heart failure
* severe hypertension
* increased bleeding risk
* thrombolytic therapy within 24 hours preceding randomization
C: Inclusion criteria:

1. Patients aged 18-75
2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding
D: Inclusion criteria

Inclusion criteria (selected):

* Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
* Written Informed Consent

Exclusion criteria

Exclusion criteria (selected):

* Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
* Active malignant disease or current cytostatic treatment
* Known severe renal insufficiency
* Liver disease expected to have any potential impact on survival, or elevated AST or ALT \> 2x upper limit of normal
* Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
* Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control
* Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran
* Contraindications to enoxaparin
* Participation in a clinical trial during the last 30 days

Answer: D