Coronary Stenosis Clinical Trial
Official title:
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
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.
Inclusion Criteria
- Calcium scan with Agatston score >20
- Age 35-84 years
- Subjects must provide written informed consent after the scope and nature of the
investigation has been explained to them
- Subjects should be stable on their concomitant medications for at least 12 weeks prior
to randomization
- Subjects who agree to refrain from supplemental garlic or significant dietary garlic
Exclusion Criteria
- A contraindication to Aged Garlic Extract therapy including: known hypersensitivity to
drug.
- Any unstable medical, psychiatric or substance abuse disorder that in the opinion of
the investigator or principal investigator is likely to affect the subject's ability to
complete the study or precludes the subject's participation in the study
- Weight in excess of 325 pounds
- Bleeding disorder
- History of myocardial infarction, stroke or life-threatening arrhythmia within the
prior six months
- Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a
resting blood pressure > 170 mm Hg or a resting diastolic blood pressure of >110 mm Hg)
- NYHA Class III or IV heart failure
- History of malignancy within the last 5 years (other than skin cancer) or evidence of
active cancer which would require concomitant cancer chemotherapy
- Serum creatinine > 1.4 mg/dl
- Triglycerides > 400 at visit 1
- Diabetic subjects with HbA1c > 12%
- Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
- Concurrent enrollment in another placebo-controlled trial
- Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude
accurate measure of coronary calcification
- Partial ileal bypass or known gastrointestinal disease limiting drug absorption
- Current intake of garlic supplement or other prohibited drug (Appendix B)
- Current tobacco use
- Current use of anticoagulants (except for antiplatelet agents)
- Chronic renal failure
- Hematological or biochemical values at screening outside the reference ranges
considered as clinically significant in the opinion of the investigator or PI
Outcome Measures Primary - Rate of change in total coronary calcium scores by CT The
Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The
density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3
for 300-399 HU, and 4 for 400 HU and greater.
Secondary Change in blood values and endothelial function over 6 and 12 months:
1. Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol,
HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method;
2. Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as
GSH
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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