Diabetes MellitusPhase 4NCT03700645
Allopurinol in Diabetes Mellitus and Multivessel Coronary Artery Disease
A Phase 4 study testing Allopurinol in people with Diabetes Mellitus and Ischemic Heart Disease, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Atherosclerosis is a progressive disease of the arterial wall, arising from the combination of endothelial dysfunction and inflammation. This link is exacerbated in diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Ischemic Heart Disease, Multi Vessel Coronary Artery Disease
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 31 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Coronary Syndrome with positive troponin
- Patients with known or newly diagnosed diabetes mellitus with HbA1c above 7% and below 10%
- Patients above the age of 40
- Stable Hemodynamic state (At least 12 hours from presentation with acute coronary syndrome)
- Uric Acid > 6mg/dl or 355 micromol/l (males) and >5mg/dl or 297 Micromol/l (females)
Who cannot join
- HbA1c below 7% or above 10%
- Severe valvular insufficiency/Stenosis
- Major surgery within 30 days
- Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
- Known intolerance/ current use of allopurinol/colchicine
- Chronic inflammatory diseases: e.g. Lupus, rheumatoid arthritis, etc.
Show all 10Show fewer
- Current treatment with steroids, NSAID, chemotherapy or biologic medications
- Extra-cardiac illness that is expected to limit survival to less than 2 years.
- Past Cancer within the past 5 years (excluding BCC and SCC).
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Allopurinol in the Treatment of Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease Treated by Either PCI or CABG: Pilot Study
Atherosclerosis is a progressive disease of the arterial wall, arising from the combination of endothelial dysfunction and inflammation. This link is exacerbated in diabetic patients.
Uric acid is known to generate oxidative stress and it's elevated levels has been shown to be associated with cardiac hypertrophy, inflammation, myocardial fibrosis and diastolic dysfunction. Allopurinol inhibits xanthine oxidase, an enzyme that regulates uric acid production. In observational studies it has been shown to reduce ischemia, inflammation and improve coronary flow. The aim of this study is to see whether treatment with Allopurinol in patients diagnosed with multivessel disease and undergoing treatment with either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) , will reduce markers of inflammation and improve quality of life and major adverse cardiovascular effects (MACE).
Read the detailed description
This is a pilot study, PROBE design (prospective randomized open label blinded endpoints study), that will include 100 patients.
Patients will be recruited during their hospitalization in the cardiology department of Ichilov- Tel-Aviv Sourasky Medical Center.
It will include patients with known or newly diagnosed diabetes mellitus, hospitalized with diagnosis of acute coronary syndrome and multi-vessel coronary artery disease (CAD) that will be demonstrated by cardiac catheterization that the patients will undergo during their hospitalization in concordance with their diagnosis and practice guidelines.
The decision about intervention with either PCI or CABG will be accepted by a heart team after the initial demonstration of multi-vessel disease.
Study recruitment will take place either in the first 24 hours after PCI or before CABG.
All patients will sign an informed consent and randomized before any intervention is done.
After enrollment, patients will undergo the following baseline procedure (no later than 24 hours from PCI):
- Physical examination and medical interview
- Quality of life questionnaires (Seattle angina , EQ-5D)
- Echocardiogram
- Blood tests- see below for description
- Endothelial function using the EndoPat®
Blood sampling will be done via IV cannula that will be placed in an antecubital vein. Blood sample analyses will be performed using reagents, calibrators and control materials in the local labs of each participating site. A 40 ml blood sample will be obtained for the following blood tests
- Full chemistry including: lipid levels, thyroid function, liver enzymes function, Troponin, BNP, HbA1c, uric acid, creatinine and glucose levels.
- Blood count
- Inflammatory biomarker (hs-CRP, fibrinogen, IL-6, IL-1B, IL-18, MMP, IL-10, IL-35, TNFa, AchE , PAI-1, MPO, cholinergic status.)
- Endothelial function markers: Endothelin-1, I-CAM, V-CAM, superoxide dismutase ADMA, and oxidized LDL
- Oxidative Stress- superoxide dismutase ADMA, and oxidized LDL, Plasma protein carbonyls.
- Urine samples- microalbuminuria, albumin/creatinine. Uric acid.
Endothelial function will be assessed using EndoPAT 2000 device (Itamar Medical Inc., Caesarea, Israel) that is a device that measures endothelial function using a sensor placed on the fingers. This device has been validated and used previously to assess peripheral arterial tone in other populations. EndoPAT bio-sensors are placed on the index fingers of both arms. EndoPAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff). When the cuff is released, the surge of blood flow causes an endothelium-dependent Flow Mediated Dilatation (FMD). The dilatation, manifested as reactive hyperemia, is captured by EndoPAT as an increase in the PAT Signal amplitude. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index. In addition, the EndoPAT system will measure heart rate variability.
After randomization and assessment as described above, the patients will receive treatment according to the study arm they were assigned to which will include either standard medical therapy alone, or standard medical therapy and allopurinol.
Allopurinol will be given initially at 100 mg once daily dose, with dose escalation by 100 mg every 2 weeks till final dose of 300 mg daily will be reached.
After discharge, patients will be assessed several times:
- One month after in cardiology clinic. Assessment will include all the tests as in the pre study exam (see above). also, patients will be monitored for the possible side effects of allopurinol treatment.
- Three months- in cardiology clinic. Assessment will include all the tests as in the pre study exam (see above).
- Being tested
- Allopurinol
- Keywords
- Diabetes Mellitus, Uric asid, Multi Vessel Coronary Artery Disease
- Medical subject headings
- Diabetes Mellitus, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Alloril
Allopurinol
| Study group | Role | What they receive |
|---|---|---|
| PCI and standard medical treatment | No intervention | Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by PCI and receive standard medical treatment according to practice guidelines. |
| PCI, standard treatment and Allopurinol | Active comparator | Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by PCI and in addition to standard medical treatment, receive treatment with allopurinol. Receives: Drug: Allopurinol |
| CABG and standard medical treatment | No intervention | Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by CABG and receive standard medical treatment according to practice guidelines. |
| CABG standard treatment and Allopurinol | Active comparator | Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by CABG and in addition to standard medical treatment, receive treatment with allopurinol. Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-CRP
Change in inflammatory biomarkers
Measured: 3 months.
Secondary outcomes (12)
hs-CRP
Change in inflammatory biomarkers
Measured: one month
Endothelial function markers
Endothelin-1, I-CAM, V-CAM, superoxide dismutase ADMA, and oxidized LDL, Change of RH-PAT
Measured: 3 month
Heart rate variability
Heart rate variability
Measured: 3 month
functional status and quality of life: the Seattle angina questionnaire
Quality of life evaluation- evaluates functional limitation in different activities due to chest pain and angina
Measured: 3 month
Uric acid levels
Uric acid levels
Measured: one month and 3 month
functional status, quality of life: EuroQol EQ-5D questionnaire
evaluation of degree of limitation in different daily activities
Measured: 3 month
Reduction of peri-procedural myocardial infarction
Reduction of peri-procedural myocardial infarction
Measured: 72 hours
MACE
major adverse cardiac events
Measured: 3 month
Diastolic function
Diastolic function per echocardiogram- E/A
Measured: 3 month
Diastolic function
Diastolic function per echocardiogram-E/E' med
Measured: 3 month
Diastolic function
Diastolic function per echocardiogram- E/E' lat
Measured: 3 month
Diastolic function
Diastolic function per echocardiogram- DT time
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Dec 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Yaron Arbel, M.D, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700645
- Sponsor's protocol ID
- TASMC-18-YA-354-18-CTIL
- Status last verified
- Nov 2018
- First submitted
- 15 Aug 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
PubMed 9887164Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009 Jan 8;360(2):129-39. doi: 10.1056/NEJMoa0808431. Epub 2008 Dec 17.
PubMed 19092145ACCORD Study Group; Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, Goff DC Jr, Probstfield JL, Cushman WC, Ginsberg HN, Bigger JT, Grimm RH Jr, Byington RP, Rosenberg YD, Friedewald WT. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011 Mar 3;364(9):818-28. doi: 10.1056/NEJMoa1006524.
PubMed 21366473BARI 2D Study Group; Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, Hlatky MA, Jones TL, Molitch ME, Nesto RW, Sako EY, Sobel BE. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009 Jun 11;360(24):2503-15. doi: 10.1056/NEJMoa0805796. Epub 2009 Jun 7.
PubMed 19502645Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.
PubMed 23796131Arbel Y, Zlotnik M, Halkin A, Havakuk O, Berliner S, Herz I, Rabinovich I, Keren G, Bazan S, Finkelstein A, Banai S. Admission glucose, fasting glucose, HbA1c levels and the SYNTAX score in non-diabetic patients undergoing coronary angiography. Clin Res Cardiol. 2014 Mar;103(3):223-7. doi: 10.1007/s00392-013-0641-7. Epub 2013 Nov 24.
PubMed 24271460de Mulder M, Umans VA, Cornel JH, van der Zant FM, Stam F, Oemrawsingh RM, Akkerhuis KM, Boersma E. Intensive glucose regulation in hyperglycemic acute coronary syndrome: results of the randomized BIOMarker study to identify the acute risk of a coronary syndrome-2 (BIOMArCS-2) glucose trial. JAMA Intern Med. 2013 Nov 11;173(20):1896-904. doi: 10.1001/jamainternmed.2013.10074.
PubMed 24018647Yang SW, Zhou YJ, Tian XF, Pan GZ, Liu YY, Zhang J, Guo ZF, Chen SY, Gao ST, Du J, Jia DA, Fang Z, Hu B, Han HY, Gao F, Hu DY, Xu YY; Beijing Heart and Metabolism Survey Study Group. Association of dysglycemia and all-cause mortality across the spectrum of coronary artery disease. Mayo Clin Proc. 2013 Sep;88(9):930-41. doi: 10.1016/j.mayocp.2013.05.022.
PubMed 24001485Neogi T, George J, Rekhraj S, Struthers AD, Choi H, Terkeltaub RA. Are either or both hyperuricemia and xanthine oxidase directly toxic to the vasculature? A critical appraisal. Arthritis Rheum. 2012 Feb;64(2):327-38. doi: 10.1002/art.33369.
PubMed 21953377Richette P, Perez-Ruiz F, Doherty M, Jansen TL, Nuki G, Pascual E, Punzi L, So AK, Bardin T. Improving cardiovascular and renal outcomes in gout: what should we target? Nat Rev Rheumatol. 2014 Nov;10(11):654-61. doi: 10.1038/nrrheum.2014.124. Epub 2014 Aug 19.
PubMed 25136785Jia G, Habibi J, Bostick BP, Ma L, DeMarco VG, Aroor AR, Hayden MR, Whaley-Connell AT, Sowers JR. Uric acid promotes left ventricular diastolic dysfunction in mice fed a Western diet. Hypertension. 2015 Mar;65(3):531-9. doi: 10.1161/HYPERTENSIONAHA.114.04737. Epub 2014 Dec 8.
PubMed 25489061Baena CP, Lotufo PA, Mill JG, Cunha Rde S, Bensenor IJ. Serum Uric Acid and Pulse Wave Velocity Among Healthy Adults: Baseline Data From the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). Am J Hypertens. 2015 Aug;28(8):966-70. doi: 10.1093/ajh/hpu298. Epub 2015 Jan 21.
PubMed 25609603Puddu P, Puddu GM, Cravero E, Vizioli L, Muscari A. Relationships among hyperuricemia, endothelial dysfunction and cardiovascular disease: molecular mechanisms and clinical implications. J Cardiol. 2012 May;59(3):235-42. doi: 10.1016/j.jjcc.2012.01.013. Epub 2012 Mar 6.
PubMed 22398104Gotsman I, Keren A, Lotan C, Zwas DR. Changes in uric acid levels and allopurinol use in chronic heart failure: association with improved survival. J Card Fail. 2012 Sep;18(9):694-701. doi: 10.1016/j.cardfail.2012.06.528. Epub 2012 Aug 3.
PubMed 22939038Miyaoka T, Mochizuki T, Takei T, Tsuchiya K, Nitta K. Serum uric acid levels and long-term outcomes in chronic kidney disease. Heart Vessels. 2014 Jul;29(4):504-12. doi: 10.1007/s00380-013-0396-0. Epub 2013 Aug 9.
PubMed 23929090
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allopurinol in the Treatment of Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease Treated by Either PCI or CABG: Pilot Study
- ClinicalTrials.gov ID
- NCT03700645
- Acronym / sponsor ID
- TASMC-18-YA-354-18-CTIL
- Keywords
- Diabetes Mellitus, Uric asid, Multi Vessel Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atherosclerosis is a progressive disease of the arterial wall, arising from the combination of endothelial dysfunction and inflammation. This link is exacerbated in diabetic patients.
Uric acid is known to generate oxidative stress and it's elevated levels has been shown to be associated with cardiac hypertrophy, inflammation, myocardial fibrosis and diastolic dysfunction. Allopurinol inhibits xanthine oxidase, an enzyme that regulates uric acid production. In observational studies it has been shown to reduce ischemia, inflammation and improve coronary flow. The aim of this study is to see whether treatment with Allopurinol in patients diagnosed with multivessel disease and undergoing treatment with either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) , will reduce markers of inflammation and improve quality of life and major adverse cardiovascular effects (MACE).
Detailed description
This is a pilot study, PROBE design (prospective randomized open label blinded endpoints study), that will include 100 patients.
Patients will be recruited during their hospitalization in the cardiology department of Ichilov- Tel-Aviv Sourasky Medical Center.
It will include patients with known or newly diagnosed diabetes mellitus, hospitalized with diagnosis of acute coronary syndrome and multi-vessel coronary artery disease (CAD) that will be demonstrated by cardiac catheterization that the patients will undergo during their hospitalization in concordance with their diagnosis and practice guidelines.
The decision about intervention with either PCI or CABG will be accepted by a heart team after the initial demonstration of multi-vessel disease.
Study recruitment will take place either in the first 24 hours after PCI or before CABG.
All patients will sign an informed consent and randomized before any intervention is done.
After enrollment, patients will undergo the following baseline procedure (no later than 24 hours from PCI):
- Physical examination and medical interview
- Quality of life questionnaires (Seattle angina , EQ-5D)
- Echocardiogram
- Blood tests- see below for description
- Endothelial function using the EndoPat®
Blood sampling will be done via IV cannula that will be placed in an antecubital vein. Blood sample analyses will be performed using reagents, calibrators and control materials in the local labs of each participating site. A 40 ml blood sample will be obtained for the following blood tests
- Full chemistry including: lipid levels, thyroid function, liver enzymes function, Troponin, BNP, HbA1c, uric acid, creatinine and glucose levels.
- Blood count
- Inflammatory biomarker (hs-CRP, fibrinogen, IL-6, IL-1B, IL-18, MMP, IL-10, IL-35, TNFa, AchE , PAI-1, MPO, cholinergic status.)
- Endothelial function markers: Endothelin-1, I-CAM, V-CAM, superoxide dismutase ADMA, and oxidized LDL
- Oxidative Stress- superoxide dismutase ADMA, and oxidized LDL, Plasma protein carbonyls.
- Urine samples- microalbuminuria, albumin/creatinine. Uric acid.
Endothelial function will be assessed using EndoPAT 2000 device (Itamar Medical Inc., Caesarea, Israel) that is a device that measures endothelial function using a sensor placed on the fingers. This device has been validated and used previously to assess peripheral arterial tone in other populations. EndoPAT bio-sensors are placed on the index fingers of both arms. EndoPAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff). When the cuff is released, the surge of blood flow causes an endothelium-dependent Flow Mediated Dilatation (FMD). The dilatation, manifested as reactive hyperemia, is captured by EndoPAT as an increase in the PAT Signal amplitude. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index. In addition, the EndoPAT system will measure heart rate variability.
After randomization and assessment as described above, the patients will receive treatment according to the study arm they were assigned to which will include either standard medical therapy alone, or standard medical therapy and allopurinol.
Allopurinol will be given initially at 100 mg once daily dose, with dose escalation by 100 mg every 2 weeks till final dose of 300 mg daily will be reached.
After discharge, patients will be assessed several times:
- One month after in cardiology clinic. Assessment will include all the tests as in the pre study exam (see above). also, patients will be monitored for the possible side effects of allopurinol treatment.
- Three months- in cardiology clinic. Assessment will include all the tests as in the pre study exam (see above).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCI and standard medical treatment | No intervention | –Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by PCI and receive standard medical treatment according to practice guidelines. |
| PCI, standard treatment and Allopurinol | Active comparator | Drug: AllopurinolPatients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by PCI and in addition to standard medical treatment, receive treatment with allopurinol. |
| CABG and standard medical treatment | No intervention | –Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by CABG and receive standard medical treatment according to practice guidelines. |
| CABG standard treatment and Allopurinol | Active comparator | Drug: AllopurinolPatients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by CABG and in addition to standard medical treatment, receive treatment with allopurinol. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute Coronary Syndrome with positive troponin
- Patients with known or newly diagnosed diabetes mellitus with HbA1c above 7% and below 10%
- Patients above the age of 40
- Stable Hemodynamic state (At least 12 hours from presentation with acute coronary syndrome)
- Uric Acid > 6mg/dl or 355 micromol/l (males) and >5mg/dl or 297 Micromol/l (females)
Key exclusion criteria (10 listed)
- HbA1c below 7% or above 10%
- Severe valvular insufficiency/Stenosis
- Major surgery within 30 days
- Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
- Known intolerance/ current use of allopurinol/colchicine
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 |
|---|---|---|
| AllopurinolAlso: AllorilAllopurinol | Drug | CABG standard treatment and Allopurinol, PCI, standard treatment and Allopurinol |
Primary outcome
hs-CRP
Time frame: 3 months.
Change in inflammatory biomarkers
12 secondary outcomes
hs-CRP
Time frame: one month
Endothelial function markers
Time frame: 3 month
Heart rate variability
Time frame: 3 month
functional status and quality of life: the Seattle angina questionnaire
Time frame: 3 month
Uric acid levels
Time frame: one month and 3 month
functional status, quality of life: EuroQol EQ-5D questionnaire
Time frame: 3 month
Reduction of peri-procedural myocardial infarction
Time frame: 72 hours
MACE
Time frame: 3 month
Diastolic function
Time frame: 3 month
Diastolic function
Time frame: 3 month
Diastolic function
Time frame: 3 month
Diastolic function
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Background: PubMed 9887164Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
- Background: PubMed 19092145Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009 Jan 8;360(2):129-39. doi: 10.1056/NEJMoa0808431. Epub 2008 Dec 17.
- Background: PubMed 21366473ACCORD Study Group; Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, Goff DC Jr, Probstfield JL, Cushman WC, Ginsberg HN, Bigger JT, Grimm RH Jr, Byington RP, Rosenberg YD, Friedewald WT. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011 Mar 3;364(9):818-28. doi: 10.1056/NEJMoa1006524.
- Background: PubMed 19502645BARI 2D Study Group; Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, Hlatky MA, Jones TL, Molitch ME, Nesto RW, Sako EY, Sobel BE. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009 Jun 11;360(24):2503-15. doi: 10.1056/NEJMoa0805796. Epub 2009 Jun 7.
- Background: PubMed 23796131Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.
- Background: PubMed 24271460Arbel Y, Zlotnik M, Halkin A, Havakuk O, Berliner S, Herz I, Rabinovich I, Keren G, Bazan S, Finkelstein A, Banai S. Admission glucose, fasting glucose, HbA1c levels and the SYNTAX score in non-diabetic patients undergoing coronary angiography. Clin Res Cardiol. 2014 Mar;103(3):223-7. doi: 10.1007/s00392-013-0641-7. Epub 2013 Nov 24.
- Background: PubMed 24018647de Mulder M, Umans VA, Cornel JH, van der Zant FM, Stam F, Oemrawsingh RM, Akkerhuis KM, Boersma E. Intensive glucose regulation in hyperglycemic acute coronary syndrome: results of the randomized BIOMarker study to identify the acute risk of a coronary syndrome-2 (BIOMArCS-2) glucose trial. JAMA Intern Med. 2013 Nov 11;173(20):1896-904. doi: 10.1001/jamainternmed.2013.10074.
- Background: PubMed 24001485Yang SW, Zhou YJ, Tian XF, Pan GZ, Liu YY, Zhang J, Guo ZF, Chen SY, Gao ST, Du J, Jia DA, Fang Z, Hu B, Han HY, Gao F, Hu DY, Xu YY; Beijing Heart and Metabolism Survey Study Group. Association of dysglycemia and all-cause mortality across the spectrum of coronary artery disease. Mayo Clin Proc. 2013 Sep;88(9):930-41. doi: 10.1016/j.mayocp.2013.05.022.
- Background: PubMed 21953377Neogi T, George J, Rekhraj S, Struthers AD, Choi H, Terkeltaub RA. Are either or both hyperuricemia and xanthine oxidase directly toxic to the vasculature? A critical appraisal. Arthritis Rheum. 2012 Feb;64(2):327-38. doi: 10.1002/art.33369.
- Background: PubMed 25136785Richette P, Perez-Ruiz F, Doherty M, Jansen TL, Nuki G, Pascual E, Punzi L, So AK, Bardin T. Improving cardiovascular and renal outcomes in gout: what should we target? Nat Rev Rheumatol. 2014 Nov;10(11):654-61. doi: 10.1038/nrrheum.2014.124. Epub 2014 Aug 19.
- Background: PubMed 25489061Jia G, Habibi J, Bostick BP, Ma L, DeMarco VG, Aroor AR, Hayden MR, Whaley-Connell AT, Sowers JR. Uric acid promotes left ventricular diastolic dysfunction in mice fed a Western diet. Hypertension. 2015 Mar;65(3):531-9. doi: 10.1161/HYPERTENSIONAHA.114.04737. Epub 2014 Dec 8.
- Background: PubMed 25609603Baena CP, Lotufo PA, Mill JG, Cunha Rde S, Bensenor IJ. Serum Uric Acid and Pulse Wave Velocity Among Healthy Adults: Baseline Data From the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). Am J Hypertens. 2015 Aug;28(8):966-70. doi: 10.1093/ajh/hpu298. Epub 2015 Jan 21.
- Individual participant dataSharing planned: No
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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.
Yaron Arbel, M.D principal investigator
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Diabetes Mellitus and Ischemic Heart Disease, run by Tel-Aviv Sourasky Medical Center.
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 10 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: status not confirmed, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia Kofman, M.D (97239673222, natalia.kofman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hs-CRP (time frame: 3 months.). 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 NCT03700645, which also lists 39 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 21 Nov 2018.