| Trial ID: | L6847 |
| Source ID: | NCT01322711
|
| Associated Drug: |
Atorvastatin
|
| Title: |
Atorvastatin, Aspirin, Oxidative Stress, Coagulation and Platelet Activation Indexes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Hypercholesterolemia
|
| Interventions: |
DRUG: Atorvastatin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Evaluation of effect of Atorvastatin Therapy in Hypercholesterolemic Patients (n=30) and Diabetic Patients (n=30), In Hypercholesterolemic patients (n=30) and in Diabetic patients (n=30) under chronic treatment with low dose aspirin (100 mg daily for at least 30 days), blood and urine samples were taken at each above reported time to evaluate the effect of atorvastatin or no treatment (Diet) on platelet recruitment, platelet and serum isoprostanes, platelet and serum thromboxane A2, platelet and serum NOX2 activation indexes, thrombin activation indexes, urinary excretion of thromboxane and isoprostanes., Baseline, 2 hours, 24 hours, 3 days, 7 days, 30 days |
|
| Sponsor/Collaborators: |
Sponsor: University of Roma La Sapienza
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-03
|
| Completion Date: |
2015-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-28
|
| Locations: |
Stefania Basili, Rome, 00161, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01322711
|
