None listed
Conditions
Brief summary
An independent contractor will fill and label the vials. The capsules and vials between medicine and placebo will be identical. Each vial will have a unique identifier which will allow the data to be properly decoded at the conclusion of the study. The patient and the physician/hospital staff, etc will be blinded.
Interventions
After providing informed consent, patients with bilateral symptomatic PAD requiring bilateral revascularization will undergo a unilateral atherectomy using the SilverHawk™ device. Patients will be randomly allocated to the active drug (80mg Atorvastatin) for 10 weeks in between their first and second SilverHawk procedures.
Sponsors
Robust Industries
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: 1) Bilateral lower extremity PAD requiring revascularization. Both extremities must have at least 1 de novo atherosclerotic lesion that will be excised. 2) Able to space bilateral atherectomy procedures by at least 10 weeks. 3) Willing to provide informed consent to participation in study. 4) LDL-C > 2.5mmol/L and < 6.5 mmol/L 5) TG < 4.0mmo/L 6) Not currently receiving or having taken a statin (simvastatin, lovastatin, rosuvastatin, atorvastatin, or pravastatin) or a combination product containing a statin for the previous 3 months.
Exclusion criteria
1) Patient is pregnant, breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up. Females of childbearing age who are not surgically sterilized and who are using effective contraception may enter only if an exclusionary pregnancy test is done prior to entering the study. Pregnancy testing will be repeated just prior to randomization and the end of the study. In the event of a positive test, the patient should be discontinued immediately and the Sponsor notified.2) Patient has a history or current evidence of any condition, therapy, lab abnormality, or mental/legal incapacitation that in the investigator’s judgment might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate.3) Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.4) Patient is currently participating in or has participated in a study with an investigational compound within 30 days of Visit 1. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.5) Patient has donated and/or received blood (including phlebotomy of >300 mL) within 2 months prior to study, or intends to donate blood or blood products during the study.6) Patient has had surgery or significant trauma within 2 months prior to Visit 1.7) Patient was <80% compliant with dosing during the placebo run-in period AND, in the opinion of the investigator, believed to be unable to maintain at least an 80% compliance with dosing during the active study dosing period.8) Patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.9) Patient has chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV.10) Patient has any known clinically significant AV conduction disturbances or arrhythmias which are not adequately controlled by medication or implantable devices.11) Patient has unstable hypertension (e.g., sitting systolic blood pressure >160 mm Hg or diastolic >100 mm Hg) at Visit 1. 12) Patient has any known clinically important bleeding or platelet disorder.13) Patient has history of ileal bypass, gastric bypass, other significant condition associated with malabsorption.14) Patient has ANY contraindication to atorvastatin therapy (as outlined in product’s prescribing information).15) Patients with significantly elevated TSH at Visit 1 may be entered after consultation with and approval by the SPONSOR. Patients with a history of hypothyroidism, who are on a stable dose of thyroxine with normal TSH level at Visit 1 may be included.16) Patients on cyclical estrogen medications (Estrogen Replacement Therapy [ERT] or oral contraceptives). Patients on non-cyclical estrogen replacement therapy or Selective Estrogen Receptor Modulator (SERM) may be included, but must be on a stable dose for at least 8 weeks prior to Visit 1 and provided that they plan to stay on the same regimen for the duration of the study.17) Patient with a history of neoplastic disease. Exception: (1) patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; (2) patients with other malignancies which have been successfully treated ³10 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening; and (3) patients, who, in the joint opinion of the SPONSOR clinical monitor and investigator, are highly unlikely to sustain a recurrence during the duration of the study. However, patients with a history of leukemia, lymphoma, malignant melanoma, myeloproliferative disease are ineligible for the study regardless of the time since treatment.18) Patients who are unlikely to be able to remain on a stable dose of their established drug regimens during the course of the study.19)Patient has the following exclusionary laboratory values at Visit 1: Creatinine >177 mmol/L); ALT (SGPT) >2 x ULN; AST (SGOT) >2 x ULN; CK >3 x ULN20) Patient with Type 2 diabetes mellitus and: is poorly controlled (HbA1C at Prescreening >8%); is newly diagnosed (within 3 months of Visit 1); is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ±10 U of insulin) within 3 months of Visit 2.21) Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism). 22) Patient has a history of hypersensitivity to Atorvastatin or another HMG CoA reductase inhibitor.23) Medications that are potent inhibitors or inducers of CYP3A4, including cyclosporine, systemic (oral/IV) itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, HIV protease inhibitors, rifampin, phenytoin and St. John’s wort. Drugs that increase the risk of myopathy will also be prohibited: verapamil, amiodarone. Routine consumption of >1 quart of grapefruit juice/day.24) Patient has initiated lipid-modifying agents including fish oils >500 mg, Cholestin™, bile-acid sequestrants, niacin (> 200 mg /day), ezetimibe, fibrates within 6 weeks (8 weeks for fibrates) prior to Visit 2.25) History of cholelithiasis or other gallbladder disease (within 6 months from Visit 1), or other active liver disease including primary biliary cirrhosis, or pancreatitis.
Outcome results
None listed