Status:
TERMINATED
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Diabetes
Cardiovascular Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our...
Detailed Description
Cholesterol lowering medications called "statins" decrease heart disease in people with diabetes but research shows that many patients are not taking these medications, sometimes because of side effec...
Eligibility Criteria
Inclusion
- Established diagnosis of type 1 or 2 diabetes
- Age 18-80 years
- Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines
- Willingness to re-try a statin despite previous apparent intolerance
- Provision of signed informed consent
Exclusion
- Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT \>three times upper limit of normal), pregnancy or lactation
- Impaired renal function: severe renal insufficiency (creatinine clearance \<30 ml/min)
- Presence of a condition such as malignancy for which the one-year prognosis is poor
- Inability of the patient to comply with the rigorous conditions of the trial
- Any other condition deemed to render the study harmful to the participant
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00299169
Start Date
September 1 2006
End Date
November 1 2007
Last Update
January 8 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2