Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells (STOPCAP)

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. Identifier: NCT00166036
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Metabolic Syndrome X
Interventions: Drug: Atorvastatin
Drug: Pravastatin

  Participant Flow

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
Previous statin or other lipid lowering medications will be discontinued for 2 months. Subjects will be on stable medical therapy for at least 2 months before recruitment.

Reporting Groups
Atorvastatin 10 mg Once Daily for 12 Weeks
Pravastatin 80 mg Once Daily for 12 Weeks

Participant Flow:   Overall Study
    Atorvastatin 10 mg   Pravastatin 80 mg
STARTED   17   19 
COMPLETED   17   19 

  Baseline Characteristics

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
Atorvastatin 10 mg Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
Pravastatin 80 mg Subject treated with oral Pravastatin 80 mg for 12 Weeks.
Total Total of all reporting groups

Baseline Measures
   Atorvastatin 10 mg   Pravastatin 80 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   19   36 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   16   18   34 
>=65 years   1   1   2 
[Units: Years]
Mean (Standard Deviation)
 54.2  (6.6)   51.7  (10.8)   52.9  (9.1) 
[Units: Participants]
Female   09   14   23 
Male   08   05   13 

  Outcome Measures

1.  Primary:   Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels   [ Time Frame: Baseline &12 Weeks ]

2.  Secondary:   Change in Flow-mediated Dilatation (FMD)   [ Time Frame: Baseline & 12 Weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
Detection of changes in Oxidative stress with significance requires a much larger cohort study.

  More Information

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: Arshed A Quyyumi, MD
Organization: Emory University
phone: 404 712 2741

Publications of Results:

Responsible Party: Arshed A. Quyyumi, Emory University Identifier: NCT00166036     History of Changes
Other Study ID Numbers: 1038-2004
First Submitted: September 12, 2005
First Posted: September 14, 2005
Results First Submitted: June 8, 2012
Results First Posted: September 8, 2014
Last Update Posted: September 8, 2014