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Trial registered on ANZCTR


Registration number
ACTRN12606000113550
Ethics application status
Approved
Date submitted
16/03/2006
Date registered
30/03/2006
Date last updated
30/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Anti-atherosclerosis Drug Evaluation Platform
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Atorvastatin on Cardiovascular Disease Biomarkers in Lower Extremity Atherosclerotic Plaque Excised from Patients with Peripheral Arterial Disease
Universal Trial Number (UTN)
Trial acronym
ADEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 1078 0
Condition category
Condition code
Cardiovascular 1158 1158 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 940 0
Treatment: Drugs
Comparator / control treatment
Patients will be randomly allocated to the matching placebo (oral administration) for 10 weeks in between their first and second SilverHawk procedures.
Control group
Placebo

Outcomes
Primary outcome [1] 1559 0
Assess the effect of drug treatment on protein markers in patients with PAD
Timepoint [1] 1559 0
After 10 weeks of treatment
Secondary outcome [1] 2811 0
NA
Timepoint [1] 2811 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Bottles of study drug will be provided to the investigator, packaged by allocation number. The assignment to either active drug or to placebo will be automatically determined by the allocation number that the investigator assigned to the patient prior to the procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized using a statistical software package.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1266 0
Commercial sector/Industry
Name [1] 1266 0
FoxHollow Technologies
Address [1] 1266 0
Country [1] 1266 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Robust Industries
Address
Country
Australia
Secondary sponsor category [1] 1121 0
None
Name [1] 1121 0
None
Address [1] 1121 0
Country [1] 1121 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36329 0
Address 36329 0
Country 36329 0
Phone 36329 0
Fax 36329 0
Email 36329 0
Contact person for public queries
Name 10129 0
Robert Whitbourn
Address 10129 0
St Vincent's Health Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 10129 0
Australia
Phone 10129 0
+61 3 92882211
Fax 10129 0
+61 3 92884441
Email 10129 0
Robert.WHITBOURN@SVHM.org.au
Contact person for scientific queries
Name 1057 0
Ross Prpic
Address 1057 0
Pacific Clinical Research Group (PCRG)
PO Box 139
Mosman NSW 2088
Country 1057 0
Australia
Phone 1057 0
+61 2 99299864
Fax 1057 0
+61 2 93838043
Email 1057 0
ross.prpic@pcrg.com.au

No data has been provided for results reporting
Summary results
Not applicable