CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00620542
First received: February 6, 2008
Last updated: July 11, 2012
Last verified: July 2012
Results First Received: May 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Coronary Atherosclerosis
Interventions: Drug: Rosuvastatin
Drug: Atorvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2333 Coronary Artery Disease (CAD) patients with clinical indication for coronary angiography were randomized to Part A, the 2-week run-in period. Of these, 1578 patients were treated and 1385 completed Part A. The 1385 patients completing Part A were then randomized to Part B the core study period of 104 weeks of treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Angiography was performed to determine if patients were qualified to continue in the study based on protocol-specified angiographic criteria. Patients who satisfied all inclusion and exclusion criteria had an Intravascular Ultrasound (IVUS) performed within 2 weeks of the qualifying angiography.

Reporting Groups
  Description
Rosuvastatin 20 mg 2 week run-in period
Atorvastatin 40 mg 2 week run-in period
Rosuvastatin 40 mg 2 year core study
Atorvastatin 80 mg 2 year core study

Participant Flow for 2 periods

Period 1:   Part A (Run-in - 2 Weeks)
    Rosuvastatin 20 mg     Atorvastatin 40 mg     Rosuvastatin 40 mg     Atorvastatin 80 mg  
STARTED     1167 [1]   1166 [2]   0     0  
Received Treatment     783     795     0     0  
COMPLETED     695     690     0     0  
NOT COMPLETED     472     476     0     0  
Adverse Event                 12                 15                 0                 0  
Protocol Violation                 406                 409                 0                 0  
Withdrawal by Subject                 43                 40                 0                 0  
Lost to Follow-up                 7                 6                 0                 0  
Protocol Violation                 0                 1                 0                 0  
Safety reasons                 0                 1                 0                 0  
IVUS not available                 4                 4                 0                 0  
[1] Of 1167 randomized, N=783 received treatment.
[2] Of 1166 randomized, N=795 received treatment.

Period 2:   Part B (2 Year Core Study)
    Rosuvastatin 20 mg     Atorvastatin 40 mg     Rosuvastatin 40 mg     Atorvastatin 80 mg  
STARTED     0     0     694 [1]   691 [2]
Received Treatment     0     0     691     689  
Intent-to-treat Population     0     0     520 [3]   519 [3]
COMPLETED     0     0     546     547  
NOT COMPLETED     0     0     148     144  
Adverse Event                 0                 0                 46                 49  
Protocol Violation                 0                 0                 3                 5  
Withdrawal by Subject                 0                 0                 55                 54  
Lost to Follow-up                 0                 0                 20                 9  
Protocol Violation                 0                 0                 13                 16  
Safety reasons                 0                 0                 2                 3  
Study specific discontinuation criteris                 0                 0                 6                 6  
IVUS not available                 0                 0                 3                 2  
[1] Of 694 patients randomized, N=691 received treatment.
[2] Of 691 patients randomized, N=689 received treatment.
[3] Patients who received treatment and had a baseline and end of study (Week 104) IVUS



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rosuvastatin 40 mg 2 years
Atorvastatin 80 mg 2 years
Total Total of all reporting groups

Baseline Measures
    Rosuvastatin 40 mg     Atorvastatin 80 mg     Total  
Number of Participants  
[units: participants]
  520     519     1039  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     402     395     797  
>=65 years     118     124     242  
Age  
[units: years]
Mean ± Standard Deviation
     
Age (yrs) at Week 0     57.4  ± 8.60     57.9  ± 8.50     57.6  ± 8.55  
Gender  
[units: Participants]
     
Female     141     133     274  
Male     379     386     765  



  Outcome Measures
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1.  Primary:   Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)   [ Time Frame: End of study (Week 104) ]

2.  Secondary:   Numbers of Patients Showing Regression in PAV   [ Time Frame: End of study (Week 104) ]

3.  Secondary:   Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)   [ Time Frame: End of study (Week 104) ]

4.  Secondary:   Numbers of Patients Showing Regression in TAV   [ Time Frame: End of study (Week 104) ]

5.  Secondary:   Total Cholesterol Blood Level   [ Time Frame: 104 weeks ]

6.  Secondary:   LDL-C Blood Level   [ Time Frame: 104 weeks ]

7.  Secondary:   HDL-C Blood Level   [ Time Frame: 104 weeks ]

8.  Secondary:   Triglycerides Blood Level   [ Time Frame: 104 weeks ]

9.  Secondary:   Non-HDL-C Blood Level   [ Time Frame: 104 weeks ]

10.  Secondary:   LDL-C/HDL-C Blood Level   [ Time Frame: 104 weeks ]

11.  Secondary:   Total Cholesterol/HDL-C Blood Level   [ Time Frame: 104 weeks ]

12.  Secondary:   Non-HDL-C/HDL-C Blood Level   [ Time Frame: 104 weeks ]

13.  Secondary:   Apolipoprotein B Blood Level   [ Time Frame: 104 weeks ]

14.  Secondary:   Apolipoprotein A-1 Blood Level   [ Time Frame: 104 weeks ]

15.  Secondary:   Apoliprotein B/Apolipoprotein A-1 Blood Level   [ Time Frame: 104 weeks ]

16.  Secondary:   VLDL-C During the 104 Week Treatment Period   [ Time Frame: 104 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00620542     History of Changes
Other Study ID Numbers: D356IC00001, 2007-004000-13
Study First Received: February 6, 2008
Results First Received: May 22, 2012
Last Updated: July 11, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration