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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01241903
First Posted: November 16, 2010
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Susan Smyth, University of Kentucky
Results First Submitted: May 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[Units: Participants]
 26   27   53 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.5  (10.7)   57.2  (10.4)   56.0  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  34.6%      11  40.7%      20  37.7% 
Male      17  65.4%      16  59.3%      33  62.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  11.5%      3  11.1%      6  11.3% 
White      23  88.5%      24  88.9%      47  88.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      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.  


  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



Responsible Party: Susan Smyth, University of Kentucky
ClinicalTrials.gov Identifier: NCT01241903     History of Changes
Other Study ID Numbers: 10-208-F1V
First Submitted: November 12, 2010
First Posted: November 16, 2010
Results First Submitted: May 21, 2014
Results First Posted: June 24, 2014
Last Update Posted: March 28, 2017