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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01837069
Eligibility Criteria:
Inclusion Criteria:
* • ≥ 21 years of age
* Subjects undergoing open orthopedic surgery of the hip, knee or spine
* Surgery is scheduled at least 3 days after PAT visit and no more than 14 days.
* High risk subject cohort
* Coronary artery disease, or
* Cerebrovascular disease (prior stroke, TIA or carotid artery disease (\>70% stenosis), or
* Peripheral artery disease, or
* Prior Venous thromboembolism or arterial thromboembolism, or
* Age ≥ 60 years and 2 of the following
* Renal insufficiency (creatinine clearance \< 60ml/min)
* Diabetes
* COPD
* Hypertension
* Active smoker or stopped less than 30 days prior to consent
* Cancer (excluding BCC)
* Heart Failure
Exclusion Criteria:
* • Known intolerance to statins
* Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or rosuvastatin/crestor 40mg daily)
* Bilateral renal artery stenosis
* End stage renal disease (receiving dialysis or CrCl \<30ml/min)
* Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin receptor blocker (e.g. angioedema, hyperkalemia)
* Known allergy or intolerance to beta blockers
* Known sick sinus syndrome not treated with permanent pacemaker
* Known greater than first degree AV block not treated with a pacemaker
* Excessive alcohol intake
* Acute Coronary Syndrome requiring hospitalization within 1 month
* Stroke within 1 month
* Known pregnancy
* Severe co-morbid condition with life expectancy \< 6 months
* Inability to give informed consent or adhere to follow-up as per protocol
* Current participation in another investigational drug or device trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01837069
Study Brief:
Protocol Section:
NCT01837069