Status:
COMPLETED
Effect of Valsartan on Carotid Artery Disease
Lead Sponsor:
Emory University
Conditions:
Carotid Artery Diseases
Atherosclerosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan will increase the blood l...
Detailed Description
Atherosclerosis or 'hardening of the arteries' is a process that ultimately leads to the development of heart attacks, strokes, poor circulation, and death. Millions of Americans are affected by this ...
Eligibility Criteria
Inclusion
- \> 0.65 mm intima-media thickness of the carotid artery measured by ultrasound
- Males aged 21-80 years or women without child bearing potential up to age 80
- Can be on concomitant therapy with aspirin, thiazide diuretics, calcium antagonists (for treatment of hypertension), or beta-receptor antagonists.
- May be on statin if on stable dose for at least 2 months before recruitment
Exclusion
- Angiotensin-converting enzyme (ACE) inhibitor or ARB therapy in the previous 3 months.
- Initiation or change in dose of statin therapy within 2 months before the study
- Inability to return to Emory for follow-up blood drawing and MR imaging
- Age \< 21 or \> 80 years
- Premenopausal females with potential for pregnancy
- Current neoplasm
- Chronic renal failure \[creatinine \> 2.5 mg/dL\]
- Diabetes with hemoglobin (Hb) A1c \> 8.5
- Anticipated change in lipid lowering therapy
- Inability to give informed consent
- MR exclusion criteria
- Blood pressure \> 140 mmHg systolic and \> 90 mmHg diastolic
- Low-density lipoprotein (LDL) cholesterol level \>130 mg/dl
- Acute coronary syndrome within 2 months
- Acute cerebrovascular accident within 2 months
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00208767
Start Date
February 1 2005
End Date
November 1 2009
Last Update
December 8 2015
Active Locations (1)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322