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

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ClinicalTrials.gov Identifier: NCT00166036
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
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
Hypercholesterolemia
Interventions Drug: Atorvastatin
Drug: Pravastatin
Enrollment 36

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Atorvastatin 10 mg Pravastatin 80 mg
Hide Arm/Group Description Once Daily for 12 Weeks Once Daily for 12 Weeks
Period Title: Overall Study
Started 17 19
Completed 17 19
Not Completed 0 0
Arm/Group Title Atorvastatin 10 mg Pravastatin 80 mg Total
Hide Arm/Group Description Subject treated with oral Atorvastatin 10 mg for 12 Weeks. Subject treated with oral Pravastatin 80 mg for 12 Weeks. Total of all reporting groups
Overall Number of Baseline Participants 17 19 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  94.1%
18
  94.7%
34
  94.4%
>=65 years
1
   5.9%
1
   5.3%
2
   5.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 19 participants 36 participants
54.2  (6.6) 51.7  (10.8) 52.9  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
Female
09
  52.9%
14
  73.7%
23
  63.9%
Male
08
  47.1%
05
  26.3%
13
  36.1%
1.Primary Outcome
Title Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels
Hide Description Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.
Time Frame Baseline &12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin 10 mg Pravastatin 80 mg
Hide Arm/Group Description:
Atorvastatin 10 mg taken daily
Pravastatin 80 mg daily
Overall Number of Participants Analyzed 17 19
Mean (Standard Error)
Unit of Measure: nmol/mL
2.1  (0.8) 2.5  (1.0)
2.Secondary Outcome
Title Change in Flow-mediated Dilatation (FMD)
Hide Description Flow-mediated dilatation (FMD) of the brachial artery was used to asses Endothelial Function. The endothelium, by releasing nitric oxide (NO), promotes vasodilation and inhibits inflammation, thrombosis, and vascular smooth muscle cell proliferation.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.
Time Frame Baseline & 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin 10 mg Pravastatin 80 mg
Hide Arm/Group Description:
Atorvastatin 10 mg daily
Pravastatin 80 mg daily
Overall Number of Participants Analyzed 17 19
Mean (Standard Error)
Unit of Measure: Percentage of brachial artery diameter
5.9  (2.9) 6.0  (2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin 10 mg Pravastatin 80 mg
Hide Arm/Group Description Subject treated with oral Atorvastatin 10 mg for 12 Weeks. Subject treated with oral Pravastatin 80 mg for 12 Weeks.
All-Cause Mortality
Atorvastatin 10 mg Pravastatin 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atorvastatin 10 mg Pravastatin 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin 10 mg Pravastatin 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/19 (0.00%) 
Detection of changes in Oxidative stress with significance requires a much larger cohort study.
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
Responsible Party: Arshed A. Quyyumi, Emory University
ClinicalTrials.gov 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