Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction

Mayo Clinic

Status: Withdrawn

Conditions: Endothelial Dysfunction

Treatments: Drug: Atorvastatin; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00587379

328-04

2003-0359 - Pfizer

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period

Treatment:

Drug: Atorvastatin

2

Placebo Comparator group

Description:

Patients randomized to 1 40mg placebo pill per day for 6 week study

Treatment:

Drug: placebo