Coronary AtherosclerosisPhase 3NCT00860847
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
A Phase 3 study testing Aged garlic extract and Coenzyme Q10 in people with Coronary Atherosclerosis and Coronary Artery Calcification, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 84 years, men only
- Conditions the study is for
- Coronary Atherosclerosis, Coronary Artery Calcification, Coronary Stenosis
- What is being tested?
- Aged garlic extract and Coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 84 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute
Torrance, California, 90005
About this study
- 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.
- 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:
- Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo.
- 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.
- 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.
Read the 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 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:
- Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method;
- Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as GSH
- Being tested
- Aged garlic extract and Coenzyme Q10
- Keywords
- Progression of Atherosclerosis, Aged garlic extract, Biomarkers of inflammation, Coronary Plaque Volume and coronary Stenosis, Vascular function
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged garlic extract and Coenzyme Q10Dietary supplement
Also called Kyolic formula 110
AGE (1200 mg) and CoQ10 (120 mg)
| Study group | Role | What they receive |
|---|---|---|
| Aged Garlic Extract and Coenzyme Q10 | Active comparator | AGE (1200 mg) and CoQ10 (120 mg)
This is a combination of aged garlic extract and co-enzyme Q10 Receives: Dietary Supplement: Aged garlic extract and Coenzyme Q10 |
| Placebo | No intervention | placebo pills will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Matthew J Budoff, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860847
- Sponsor's protocol ID
- Wakunaga of America Co., Ltd.
- Status last verified
- Feb 2015
- First submitted
- 11 Mar 2009
- Last updated
- 12 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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. doi: 10.1016/s0002-9343(98)00041-2.
PubMed 9550502Lau BH, Li L, Yoon P. Thymic peptide protects vascular endothelial cells from hydrogen peroxide-induced oxidant injury. Life Sci. 1993;52(22):1787-96. doi: 10.1016/0024-3205(93)90468-i.
PubMed 8492641Weissberg PL, Bennett MR. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jun 17;340(24):1928-9. No abstract available.
PubMed 10375320Raggi 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. doi: 10.1161/01.ATV.0000127024.40516.ef. Epub 2004 Apr 1.
PubMed 15059806Budoff 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. doi: 10.1016/j.ypmed.2004.04.012.
PubMed 15475033Steiner 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. doi: 10.1097/00005344-199806000-00014.
PubMed 9641475BEUTLER E, DURON O, KELLY BM. Improved method for the determination of blood glutathione. J Lab Clin Med. 1963 May;61:882-8. No abstract available.
PubMed 13967893Mao 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. doi: 10.1148/radiol.2203001129.
PubMed 11526270Ahmadi 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.
PubMed 19083982
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
- ClinicalTrials.gov ID
- NCT00860847
- Acronym / sponsor ID
- Wakunaga of America Co., Ltd.
- Keywords
- Progression of Atherosclerosis, Aged garlic extract, Biomarkers of inflammation, Coronary Plaque Volume and coronary Stenosis, Vascular function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Posted 12 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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:
- Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo.
- 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.
- 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.
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 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:
- Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method;
- Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as GSH
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aged Garlic Extract and Coenzyme Q10 | Active comparator | Dietary Supplement: Aged garlic extract and Coenzyme Q10AGE (1200 mg) and CoQ10 (120 mg) This is a combination of aged garlic extract and co-enzyme Q10 |
| Placebo | No intervention | –placebo pills will be given |
Who may qualify
- Ages
- 35 to 84 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aged garlic extract and Coenzyme Q10Also: Kyolic formula 110AGE (1200 mg) and CoQ10 (120 mg) | Dietary supplement | Aged Garlic Extract and Coenzyme Q10 |
Primary outcome
Rate of Change in Total Coronary Calcium Scores by Computed Tomography
Time frame: 1 year
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 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9550502Libby 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. doi: 10.1016/s0002-9343(98)00041-2.
- Background: PubMed 8492641Lau BH, Li L, Yoon P. Thymic peptide protects vascular endothelial cells from hydrogen peroxide-induced oxidant injury. Life Sci. 1993;52(22):1787-96. doi: 10.1016/0024-3205(93)90468-i.
- Background: PubMed 10375320Weissberg PL, Bennett MR. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jun 17;340(24):1928-9. No abstract available.
- Background: PubMed 15059806Raggi 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. doi: 10.1161/01.ATV.0000127024.40516.ef. Epub 2004 Apr 1.
- Background: PubMed 15475033Budoff 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. doi: 10.1016/j.ypmed.2004.04.012.
- Background: PubMed 9641475Steiner 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. doi: 10.1097/00005344-199806000-00014.
- Background: PubMed 13967893BEUTLER E, DURON O, KELLY BM. Improved method for the determination of blood glutathione. J Lab Clin Med. 1963 May;61:882-8. No abstract available.
- Background: PubMed 11526270Mao 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. doi: 10.1148/radiol.2203001129.
- Background: PubMed 19083982Ahmadi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Budoff, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aged garlic extract and Coenzyme Q10 in people with Coronary Atherosclerosis and Coronary Artery Calcification, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Change in Total Coronary Calcium Scores by Computed Tomography (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860847, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2015.