Overview

This trial is active, not recruiting.

Conditions coronary atherosclerosis, coronary artery calcification, coronary stenosis, vascular function
Treatment aged garlic extract and coenzyme q10
Phase phase 3
Sponsor Los Angeles Biomedical Research Institute
Start date May 2009
End date August 2010
Trial size 130 participants
Trial identifier NCT00860847, Wakunaga of America Co., Ltd.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
AGE (1200 mg) and CoQ10 (120 mg)
aged garlic extract and coenzyme q10 Kyolic formula 110
AGE (1200 mg) and CoQ10 (120 mg)
(No Intervention)

Primary Outcomes

Measure
Rate of change in total coronary calcium scores by computed tomography
time frame: 1 year

Secondary Outcomes

Measure
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
time frame: 1 year

Eligibility Criteria

Male participants from 35 years up to 84 years old.

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

Additional Information

Official title Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
Principal investigator Matthew J Budoff, MD
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 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 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
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Los Angeles Biomedical Research Institute.