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CompletedNCT00235950Updated Nov 19, 2010

Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease

A Phase 4 interventional study of Rosuvastatin or atorvastatin or simvastatin and clopidogrel in Coronary Heart Disease, sponsored by AstraZeneca. Completed at 18 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-19.

Sponsored by AstraZeneca · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy between two lipid lowering treatments, rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein cholesterol (LDL-C) levels after 16 weeks of treatment in patients with coronary heart disease

02

Conditions studied

  • Coronary Heart Disease

Keywords

  • Coronary Heart Disease
  • Percutaeous Coronary Intervention (PCI)
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 255 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years or older, established coronary heart disease with a previously performed PCI, previous treatment with clopidogrel, ongoing statin treatment, LDL-C>2.9 mmol/L, signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Ongoing treatment with clopidogrel for more than 12 weeks after randomisation, hypersensitivity to any of the study drugs, active liver disease, moderate or severe renal impairment, hereditary for or known muscular or neuromuscular disease and/or increased serum CK, pregnancy or lactation or of childbearing potential not practising an adequate method of contraception, use of concomitant medication with possible interaction with
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
255 participants

Interventions

  • DrugRosuvastatin or atorvastatin or simvastatin and clopidogrel

    Also known as: Crestor

06

What researchers measure

Primary outcomes

  1. Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin

Secondary outcomes

  1. Compare the impact of treatment with rosuvastatin to that of atorvastatin and simvastatin on clopidogrel initiated inhibition of platelet aggregation in a subset of subjects recruited in the Stockholm region.

  2. Compare the impact of treatment with rosuvastatin to that of atorvastatin on clopidogrel initiated inhibition of platelet aggregation in all subjects, totally and on each dose of rosuvastatin and atorvastatin.

  3. Compare the efficacy of treatment with rosuvastatin with the efficacy of treatment with atorvastatin in reducing LDL-C levels

  4. Compare the efficacy of once daily treatment with rosuvastatin with that of atorvastatin in modifying levels of TC, HDL-C, TG, nonHDL-C (TC-HDL-C), LDL-C

  5. Compare the titration schedule of rosuvastatin with that of atorvastatin.

  6. Determine the safety by evaluating the incidence and severity of adverse events and abnormal laboratory values through 16 weeks of treatment

07

Study locations

18 sites
  • Research Site
    Danderyd, Sweden
  • Research Site
    Eksjö, Sweden
  • Research Site
    Falun, Sweden
  • Research Site
    Göteborg, Sweden
  • Research Site
    Helsingborg, Sweden
  • Research Site
    Jönköping, Sweden
  • Research Site
    Karlskrona, Sweden
  • Research Site
    Karlstad, Sweden
  • Research Site
    Ljungby, Sweden
  • Research Site
    Lund, Sweden
  • Research Site
    Malmö, Sweden
  • Research Site
    Skövde, Sweden
  • Research Site
    Stockholm, Sweden
  • Research Site
    Sundsvall, Sweden
  • Research Site
    Uppsala, Sweden
  • Research Site
    Västerås, Sweden
  • Research Site
    Växjö, Sweden
  • Research Site
    Örebro, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00235950
Lead sponsor
AstraZeneca
First posted
Oct 12, 2005
Start date
Jan 2004
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Nov 19, 2010

Study contacts

AstraZeneca Medical Science Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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