CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 65 enrolled
Drug / intervention
Aged garlic extract and Coenzyme Q10dietary
Likely dose
Aged garlic extract 1200 mg plus Coenzyme Q10 120 mg dailyAI-extracted
Key inclusion· 4
  • Coronary artery calcification with Agatston score >20
  • Age 35-84 years
  • Stable on concomitant medications for at least 12 weeks prior to randomization
  • Agreement to refrain from supplemental garlic or significant dietary garlic
Key exclusion· 11
  • Known hypersensitivity to aged garlic extract
  • Myocardial infarction, stroke, or life-threatening arrhythmia within 6 months
  • NYHA Class III or IV heart failure
  • Bleeding disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00860847
NCT00860847Phase 3Completed

Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·interventional·Posted Mar 12, 2009·Updated Mar 12, 2015

In Brief

A Phase 3 clinical trial evaluating Aged garlic extract and Coenzyme Q10 for Coronary Atherosclerosis and 2 related conditions. Completed, enrolled 65 participants across 1 site.

Detailed Summary

1. Statement of Problem According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce coronary plaque progression. However is certainly not the only factor in evaluating for progression of coronary artery disease (CAD), and other factors must play a role. Garlic therapy has been shown to retard atherosclerosis independently. 2. Hypothesis and Specific Aims The hypothesis of this proposal is: In comparison to the placebo group, Aged Garlic Extract (AGE) therapy + Coenzyme Q10 (CoQ10) will be effective in slowing progression of coronary artery calcification (CAC) in firefighters with established atherosclerosis, independent of baseline blood pressure, statin use or other cardiovascular risk factors. Specific Aims: 1. Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo. 2. Compare whether degree of change in atherosclerotic coronary artery plaque burden will change at a different rate under the influence of Aged Garlic Extract + CoQ10 compared to placebo treatment. 3. Compare whether Aged Garlic Extract + CoQ10 therapy induces changes in baseline values including biological and biochemical parameters, such as LDL cholesterol, homocysteine, C-reactive protein (CRP), and endothelial function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2009
Enrollment StartMay 1, 2009
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago

Interventions

Aged garlic extract and Coenzyme Q10dietary

AGE (1200 mg) and CoQ10 (120 mg)