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

Coronary Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860847
• Other study ID #: Wakunaga of America Co., Ltd.
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2009
• Last updated: February 28, 2015
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2015
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 84 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Calcinosis
• Coronary Artery Calcification
• Coronary Artery Disease
• Coronary Atherosclerosis
• Coronary Stenosis
• Heart Diseases
• Myocardial Ischemia

Intervention

Dietary Supplement:
• Aged garlic extract and Coenzyme Q10
AGE (1200 mg) and CoQ10 (120 mg)

Locations

Country	Name	City	State
United States	Los Angeles Biomedical Research Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (9)

Ahmadi N, Hajsadeghi F, Gul K, Vane J, Usman N, Flores F, Nasir K, Hecht H, Naghavi M, Budoff M. Relations between digital thermal monitoring of vascular function, the Framingham risk score, and coronary artery calcium score. J Cardiovasc Comput Tomogr. 2008 Nov;2(6):382-8. doi: 10.1016/j.jcct.2008.09.001. Epub 2008 Sep 26. — View Citation

BEUTLER E, DURON O, KELLY BM. Improved method for the determination of blood glutathione. J Lab Clin Med. 1963 May;61:882-8. — View Citation

Budoff MJ, Takasu J, Flores FR, Niihara Y, Lu B, Lau BH, Rosen RT, Amagase H. Inhibiting progression of coronary calcification using Aged Garlic Extract in patients receiving statin therapy: a preliminary study. Prev Med. 2004 Nov;39(5):985-91. — View Citation

Lau BH, Li L, Yoon P. Thymic peptide protects vascular endothelial cells from hydrogen peroxide-induced oxidant injury. Life Sci. 1993;52(22):1787-96. — View Citation

Libby P, Schoenbeck U, Mach F, Selwyn AP, Ganz P. Current concepts in cardiovascular pathology: the role of LDL cholesterol in plaque rupture and stabilization. Am J Med. 1998 Feb 23;104(2A):14S-18S. Review. — View Citation

Mao S, Bakhsheshi H, Lu B, Liu SC, Oudiz RJ, Budoff MJ. Effect of electrocardiogram triggering on reproducibility of coronary artery calcium scoring. Radiology. 2001 Sep;220(3):707-11. — View Citation

Raggi P, Callister TQ, Shaw LJ. Progression of coronary artery calcium and risk of first myocardial infarction in patients receiving cholesterol-lowering therapy. Arterioscler Thromb Vasc Biol. 2004 Jul;24(7):1272-7. Epub 2004 Apr 1. — View Citation

Steiner M, Lin RS. Changes in platelet function and susceptibility of lipoproteins to oxidation associated with administration of aged garlic extract. J Cardiovasc Pharmacol. 1998 Jun;31(6):904-8. — View Citation

Weissberg PL, Bennett MR. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jun 17;340(24):1928-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Change in Total Coronary Calcium Scores by Computed Tomography	progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: 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 The endpoint is the mean change (end of study value - baseline value) in each group.	1 year	No
Secondary	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		1 year	No

External Links

•   Contact Drs Budoff or Laidlaw for further information