Please select the eligibility criteria that correspond to the clinical trial below.
Title: Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People
Brief Summary: Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes is scant and controversial. While the efficacy of aspirin versus placebo in patients with diabetes is currently under investigation in big randomized controlled trials, the putative additive effects of aspirin and statins in this population remain to be investigated. Moreover there are no data examining the pathophysiologic means by which aspirin with or without statins affects thrombosis in diabetic patients.

The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily), statins, both or neither for the reduction of thrombin generation. These preventive strategies will be evaluated on the top of the other strategies aimed at optimizing the care of diabetic patients in terms of metabolic control and control of the other cardiovascular risk factors.


Options:
A: Inclusion Criteria:

* Patients with a clinical diagnosis of SLE, confirmed by a faculty rheumatologist at Johns Hopkins.
* Patients must be 18 years of age or older
* Give informed consent.

Exclusion Criteria:

* SLE patients with a known atherosclerotic event, such as angina, myocardial infarction, or stroke, with an abnormal lipid profile for which a statin would be standard of care, are excluded.
* Pregnant patients (or patients planning to become pregnant in the next two years) are excluded.
* Patients who have known chronic liver disease, have unexplained elevation of their liver enzymes greater than 2 times the upper limit of normal , or an elevated CPK greater than 1.5 times the upper limit of the normal value for the patient's racial group, are excluded.
* Patients with triglycerides greater than 500 mg/dl or LDL greater than 190 in the absence of 2 risk factors (and who are unwilling to participate in a formal nutritional/lifestyle modification program that we recommend for them) are excluded.
B: Inclusion Criteria:

* Healthy men age 60 to 75

Exclusion Criteria:

* History of significant cardiac, renal, pulmonary, hepatic, benign prostatic hyperplasia, or malignant disease, current alcohol or illicit drug abuse, or major psychiatric disorders.
* Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease.
* Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates, calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), or anti-convulsants.
* Cognitive or intellectual impairment that precludes complete understanding of the study protocol.
* History of deep vein thrombosis, pulmonary embolism, or clotting disorders.
* Serum 25-hydroxyvitamin D \< 15 ng/mL
* Serum parathyroid hormone (PTH) \< 10 or \> 65 pg/mL
* Serum thyroid stimulating hormone (TSH) \< 0.5 or \> 5.0 U/L
* Serum calcium \> 10.6 mg/dL
* Serum creatinine \> 2 mg/dL
* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2x the upper limit of normal
* Serum bilirubin \> 2 mg/dL
* Serum alkaline phosphatase \> 150 U/L
* Plasma hemoglobin \< 11 gm/dL
* Hematocrit \> 50
* Fracture within the last 6 months.
* Serum testosterone level \< 270 or \> 1070 ng/dL
* Serum prostate specific antigen (PSA) level \> 4 ug/L.
* International Prostate Symptom Score (IPSS) \> 19
* Systolic blood pressure \> 160 or diastolic blood pressure \> 95
* Framingham risk score greater than or equal to 20
* Difficulty walking 2 blocks
C: Inclusion Criteria:

* Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours.
* Total cholesterol \> 5.2 mmol/L (200 mg/dL) on diet alone.

Exclusion Criteria:

* Myocardial infarction within 2 months prior to the study.
* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
D: Inclusion Criteria:

* Diabetes mellitus treated with insulin or orl agents
* At least 50 years old

Exclusion Criteria:

* Previous cardiovascular events
* current or past (within last 30 days) treatment with aspirin
* current or past (within last 180 days) treatment with statins

Answer: D