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Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT00299169
Recruitment Status : Terminated (insufficient recruitment/enrollment)
First Posted : March 6, 2006
Last Update Posted : January 8, 2008
Sponsor:
Information provided by:
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE March 2, 2006
First Posted Date  ICMJE March 6, 2006
Last Update Posted Date January 8, 2008
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2008)
mean LDL levels [ Time Frame: end of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2006)
mean LDL-C levels
Change History Complete list of historical versions of study NCT00299169 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2008)
the proportions of participants taking statins at the end of the trial [ Time Frame: end of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2006)
the proportions of participants taking statins at the end of the trial
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
Official Title  ICMJE Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
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 hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.
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 effects. In our experience, the side effects attributed to statin therapy are often subjective, non-specific, and not associated with objective evidence for a clinically important problem. The most common example is muscle cramps despite a normal CK level, but other symptoms include fatigue, GI intolerance, and neurological symptoms.

Traditionally, the effects of treatments are determined using randomized controlled trials. N of 1 trials minimize these biases through randomization, double-blinding, and multiple crossovers, and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous.

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 hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels. Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo. Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way.

At the end of the study, we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels. We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Cardiovascular Disease
  • Hyperlipidemia
Intervention  ICMJE Behavioral: N of 1 Trials
N of 1 Trials of statin therapy
Other Name: usual care
Study Arms
  • Experimental: 1
    N of 1 trials of statin therapy
    Intervention: Behavioral: N of 1 Trials
  • 2
    usual care
    Intervention: Behavioral: N of 1 Trials
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 4, 2008)
6
Original Enrollment  ICMJE
 (submitted: March 2, 2006)
30
Actual Study Completion Date November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00299169
Other Study ID Numbers  ICMJE R-06-135
IRF-061-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charlotte G McDonald, MD University of Western Ontario, Canada
PRS Account Lawson Health Research Institute
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP