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Trial record 1 of 1 for:    NCT01304641
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Cardiovascular Events Based On Statin Initiation In The Elderly

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ClinicalTrials.gov Identifier: NCT01304641
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : April 5, 2012
Last Update Posted : April 5, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 24, 2011
First Posted Date February 25, 2011
Results First Submitted Date January 3, 2012
Results First Posted Date April 5, 2012
Last Update Posted Date April 5, 2012
Study Start Date November 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2012)
  • Number of Participants With Post-index Cardiovascular (CV) Events [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ]
    CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.
  • Hazard Ratio for First Cardiovascular (CV) Event [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ]
    Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.
Original Primary Outcome Measures
 (submitted: February 24, 2011)
  • Post-Index Cardiovascular Events. Cardiovascular events were identified using medical claims. Cardiovascular events were defined as an inpatient or emergency department admission a cardiovascular event. [ Time Frame: At least 90 days ]
  • Time to First Cardiovascular Event. The time to the first occurring cardiovascular event was captured in the post-index period and the time to the first cardiovascular event was measured. [ Time Frame: At least 90 days ]
Change History Complete list of historical versions of study NCT01304641 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 8, 2012)
  • Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ]
  • Mean Dose [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ]
    The first observed study medication fill during the participation identification period was defined as the index drug. The initial dose of the index drug was determined based on the pharmacy claims.
  • Number of Participants Per Dose [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ]
    Index dose was categorized as low dose (atorvastatin 10 mg, simvastatin up to 20 mg), medium dose (atorvastatin 20 mg, simvastatin 40 mg), and high dose (atorvastatin 40 or 80 mg, simvastatin 80 mg).
  • Length of Post-index Period [ Time Frame: Index date (baseline) up to end of study (28 February 2009) ]
    Post-index period included time during which participants were observed for a minimum of 3 months following index date (fill date on which first observed atorvastatin or simvastatin was filled during the participant identification period) until disenrollment or end of study treatment (28 February 2009).
  • Percentage of Participants Who Adhered to Index Therapy [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ]
    Percentage of participants who adhered to index therapy was evaluated. Treatment adherence was defined as the number of days covered by index medication divided by the number of days in the post-index period, expressed as a percentage.
Original Secondary Outcome Measures
 (submitted: February 24, 2011)
  • Post-Index LDL-C Testing Results. For those patients with available LDL-C test results, LDL-C was assessed in the post-index period. [ Time Frame: At least 90 days ]
  • Index Dose. The initial dose of the index drug was determined based on the pharmacy claims. [ Time Frame: At least 90 days ]
  • Index Dose Category. Index dose was categorized as low dose (atorvastatin ≤ 10 mg, simvastatin ≤ 20 mg), medium dose (10 mg < atorvastatin ≤ 20 mg, 20 mg < simvastatin ≤ 40 mg), and high dose (atorvastatin > 20 mg, simvastatin > 40 mg). [ Time Frame: At least 90 days ]
  • Duration on Index Therapy 1. Duration of therapy 1 was defined as the total number of days from index medication fill to the date of discontinuation, augmentation with another dyslipidemia medication, or the end of follow-up, whichever occurred first. [ Time Frame: At least 90 days ]
  • Index Therapy 2. Duration is the total number of days from index medication fill to the date of discontinuation, augmentation with another dyslipidemia medication, the end of follow-up, or occurrence of a cardiovascular event, whichever occurred first. [ Time Frame: At least 90 days ]
  • Proportion of days covered on index therapy was defined as the total number of days of therapy with index medication during the post-index period divided by the number of days of follow-up until the earlier of cardiovascular event or end of follow-up. [ Time Frame: At least 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Events Based On Statin Initiation In The Elderly
Official Title Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin
Brief Summary The purpose of this study is to compare rates and risk of primary cardiovascular events among elderly patients newly initiating therapy with atorvastatin or simvastatin. The specific objectives for this project are to: 1) examine the demographic and clinical characteristics of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2) compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin was newly initiated.
Detailed Description All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study included commercial health plan members and Medicare Advantage Part D enrollees ages 65 years and older with a prescription for atorvastatin or simvastatin filled between 01 July 2006 and 30 November 2008 (subject identification period). The first observed atorvastatin or simvastatin fill during the subject identification period was defined as the index drug and the fill date was defined as the index date. A 12-month period prior to the index date (defined as the pre-index period) was used for identification of comorbid exclusionary conditions. The 12-month period prior to index date was also used for assessment of pre-index patient characteristics. Patients were observed for a minimum of 3 months (following index date) until the earlier of either 1) disenrollment from the health plan or 2) 28 February 2009 (post-index period). The pre- and post-index periods in combination were defined as the analytic period.
Condition
  • Cardiovascular
  • Dyslipidemia
Intervention
  • Other: Atorvastatin Initiators
    Retrospective database analysis no intervention performed.
  • Other: Simvastatin Initiators
    Retrospective database analysis no intervention performed.
Study Groups/Cohorts
  • Atorvastatin Initiators
    Intervention: Other: Atorvastatin Initiators
  • Simvastatin Initiators
    Intervention: Other: Simvastatin Initiators
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 Completed
Actual Enrollment
 (submitted: March 8, 2012)
31603
Original Actual Enrollment
 (submitted: February 24, 2011)
31602
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ≥ 1 fill for atorvastatin or simvastatin (not including combination therapy) between 01 July 2006 and 30 November 2008
  • Age ≥ 65 years as of the year of index date
  • Continuous enrollment with medical and pharmacy benefits during the analytic period

Exclusion Criteria:

  • 1 or more fills for a statin or other dyslipidemia medication in the 12-month pre-index period
  • A pharmacy fill for clopidogrel or nitrates (except concomitant hydralazine) in the 12-month pre-index period
  • Patients with evidence of a cardiovascular event in the 12-month pre-index period.
  • Patients who received both atorvastatin and simvastatin on the index date
  • Patients with unknown gender or region
  • Patients who received dyslipidemia medications other than the index drug within 1 months (30 days) following the index date
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01304641
Other Study ID Numbers A2581188
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2012