Comparison of Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome

NCT00665834 | Completed Phase 4 DMC

• 1 other identifier: DMED 938-06
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This is a 3-month, randomized, parallel-group study with 2 periods, comparing the efficacy and the safety of rosuvastatin 20 mg versus atorvastatin 80 mg in patients with an acute coronary syndrome (ACS).

Conditions

Dyslipidemia; Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (1)

• Compare efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in measuring ApoB/ApoA ratio at 3 months in acute coronary syndrome patients receiving the study treatment after percutaneous coronary intervention (PCI).

  12 weeks

Secondary Outcomes (3)

• Efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing LDL-C 1 month and 3 months post PCI.

  12 weeks

• Efficacy of early-started rosuvastatin 20 mg versus placebo on hs-CRP from admission to start of study treatment post PCI.

  12 weeks

• Efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing ApoB/ApoA-1 ratio at 1 month.

  12 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Rosuvastatin 20 mg versus placebo 20 mg

Drug: rosuvastatin; Drug: placebo

2

ACTIVE COMPARATOR

rosuvastatin 20 mg versus atorvastatin 80 mg

Drug: rosuvastatin; Drug: atorvastatin

Interventions

rosuvastatin DRUG

rosuvastatin 20 mg from day 0 to (maximum) day 6

1

placebo DRUG

placebo 20 mg from day 0 to (maximum) day 6

1

atorvastatin DRUG

atorvastatin 80 mg from discharge until the end of the study

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women who are between 18 and 75 years old
• Patients diagnosed with non ST elevation - acute coronary syndrome (NSTE-ACS)
• Patients with onset of clinical symptoms less than 24 hours prior to their admission for which a PCI is planned or anticipated.

You may not qualify if:

• Patients with STEMI (ST elevation myocardial infarction-heart attack) and primary PCI planned within 24 hours of admission will not be included.
• Patients will not be allowed to have taken any cholesterol-lowering medications during 1 month prior to enrolment.

Sponsors & Collaborators

• Queen's University: lead
• AstraZeneca: collaborator

Study Sites (2)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Vascular Disease Prevention and Research Centre, Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Dyslipidemias; Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Stephen A LaHaye, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: April 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

CA (2)