Status:
COMPLETED
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Coronary Atherosclerosis
Coronary Artery Calcification
Eligibility:
MALE
35-84 years
Phase:
PHASE3
Brief 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 incre...
Detailed Description
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 the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00860847
Start Date
May 1 2009
End Date
September 1 2010
Last Update
March 12 2015
Active Locations (1)
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1
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90005