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

History of Changes

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

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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 ]

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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

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Other Adverse Events

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Limitations and Caveats

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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
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

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