Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan Smyth, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01241903
First received: November 12, 2010
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: May 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Coronary Syndrome
Angioplasty, Transluminal, Percutaneous Coronary
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Blood Platelets
Interventions: Drug: rosuvastatin
Drug: placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
Rosuvastatin Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.

Participant Flow:   Overall Study
    Placebo     Rosuvastatin  
STARTED     27     27  
COMPLETED     26     27  
NOT COMPLETED     1     0  



  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
Placebo Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
Rosuvastatin Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
Total Total of all reporting groups

Baseline Measures
    Placebo     Rosuvastatin     Total  
Number of Participants  
[units: participants]
  26     27     53  
Age  
[units: years]
Mean ± Standard Deviation
  54.5  ± 10.7     57.2  ± 10.4     56.0  ± 10.7  
Gender  
[units: participants]
     
Female     9     11     20  
Male     17     16     33  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     3     6  
White     23     24     47  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures

1.  Primary:   Platelet - Leukocyte Aggregates   [ Time Frame: within first 24 hours ]

2.  Secondary:   Biomarkers of Platelet Function and Myocardial Necrosis   [ Time Frame: up to 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Susan S. Smyth
Organization: University of Kentucky
phone: (859) 323-2274
e-mail: ssmyt2@uky.edu


No publications provided


Responsible Party: Susan Smyth, University of Kentucky
ClinicalTrials.gov Identifier: NCT01241903     History of Changes
Other Study ID Numbers: 10-208-F1V
Study First Received: November 12, 2010
Results First Received: May 21, 2014
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration