Phase 2 N=120 Randomized Quadruple-blind Treatment

Effect of Valsartan on Carotid Artery Disease

Carotid Artery Diseases · Atherosclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00208767 ↗

Enrolled (actual)

120

Serious AEs

2.5%

Results posted

Sep 2014

Primary outcome: Primary: Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years — -6.7; 3.4 mm2

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Valsartan (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years	-6.7; 3.4	—

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 levels of markers responsible for repair of the vessel wall, reduce oxidation and inflammation, improve the function of the blood vessels, and arrest or slow down the progression of atherosclerosis over time.

Eligibility Criteria

Inclusion Criteria

> 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 Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00208767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.