Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction
Not Applicable
Withdrawn
- Conditions
- Endothelial Dysfunction
- Interventions
- Drug: placebo
- Registration Number
- NCT00587379
- Lead Sponsor
- Mayo Clinic
- Brief Summary
To determine if 6 weeks of daily treatment with Atorvastatin 40 mg alters the immediate effect of Sildenafil Citrate (Viagra, Pfizer Inc, New York, NY) on endothelial function (activity of the artery) as measured by noninvasive peripheral arterial tonography in men and women. Also, to determine if 6 weeks of daily treatment with Atorvastatin 40 mg affects erectile function in men
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients undergoing coronary angiography
- No previous statin use
- Age > 18 years old
- No PDE5-1 use in the past 6 months
Exclusion Criteria
- Patients with an Acute Coronary Syndrome
- Patients with Cardiogenic shock
- Patients > 30% coronary stenosis
- Patients with unexplained muscle pain
- Patients with acute liver disease
- Patients receiving immunosuppressant therapy, azoles, macrolide antibiotics, niacin, L-arginine
- Patients with serum creatinine > 2.0
- Patients with total cholesterol > 200 mmol/l
- Patients on current statin therapy or clinically indicated to be on statin therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo Patients randomized to 1 40mg placebo pill per day for 6 week study 1 Atorvastatin Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period
- Primary Outcome Measures
Name Time Method To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin. 6 weeks
- Secondary Outcome Measures
Name Time Method To determine if treatment with Atovastatin affects erectile function in men 6 weeks