Allopurinol in Diabetes Mellitus and Multivessel Coronary Artery Disease
NCT ID: NCT03700645
Last Updated: 2018-11-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-12-01
Study Completion Date
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
NCT06909565
Percutaneous Coronary Intervention
Peripheral Endovascular Intervention
RECRUITING
PHASE4
ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes
NCT06469528
Coronary Artery Disease
NOT_YET_RECRUITING
PHASE3
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
NCT03399370
ASCVD
Elevated Cholesterol
COMPLETED
PHASE3
Colchicine in Percutaneous Coronary Intervention
NCT02594111
Coronary Artery Disease
Acute Coronary Syndrome
COMPLETED
PHASE4
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients
NCT06813339
Atherosclerotic Cardiovascular Disease
Acute Coronary Syndromes
RECRUITING
EARLY_PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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):
1. Physical examination and medical interview
2. Quality of life questionnaires (Seattle angina , EQ-5D)
3. Echocardiogram
4. Blood tests- see below for description
5. 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
1. Full chemistry including: lipid levels, thyroid function, liver enzymes function, Troponin, BNP, HbA1c, uric acid, creatinine and glucose levels.
2. Blood count
3. Inflammatory biomarker (hs-CRP, fibrinogen, IL-6, IL-1B, IL-18, MMP, IL-10, IL-35, TNFa, AchE , PAI-1, MPO, cholinergic status.)
4. Endothelial function markers: Endothelin-1, I-CAM, V-CAM, superoxide dismutase ADMA, and oxidized LDL
5. Oxidative Stress- superoxide dismutase ADMA, and oxidized LDL, Plasma protein carbonyls.
6. 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:
1. 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.
2. Three months- in cardiology clinic. Assessment will include all the tests as in the pre study exam (see above).
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):
1. Physical examination and medical interview
2. Quality of life questionnaires (Seattle angina , EQ-5D)
3. Echocardiogram
4. Blood tests- see below for description
5. 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
1. Full chemistry including: lipid levels, thyroid function, liver enzymes function, Troponin, BNP, HbA1c, uric acid, creatinine and glucose levels.
2. Blood count
3. Inflammatory biomarker (hs-CRP, fibrinogen, IL-6, IL-1B, IL-18, MMP, IL-10, IL-35, TNFa, AchE , PAI-1, MPO, cholinergic status.)
4. Endothelial function markers: Endothelin-1, I-CAM, V-CAM, superoxide dismutase ADMA, and oxidized LDL
5. Oxidative Stress- superoxide dismutase ADMA, and oxidized LDL, Plasma protein carbonyls.
6. 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:
1. 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.
2. Three months- in cardiology clinic. Assessment will include all the tests as in the pre study exam (see above).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Diabetes Mellitus
Ischemic Heart Disease
Multi Vessel Coronary Artery Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PCI and standard medical treatment
Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by PCI and receive standard medical treatment according to practice guidelines.
Group Type
NO_INTERVENTION
No interventions assigned to this group
PCI, standard treatment and Allopurinol
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.
Group Type
ACTIVE_COMPARATOR
Allopurinol
Intervention Type
DRUG
Allopurinol
CABG and standard medical treatment
Patients diagnosed with multi vessel disease that after Heart team discussion underwent intervention by CABG and receive standard medical treatment according to practice guidelines.
Group Type
NO_INTERVENTION
No interventions assigned to this group
CABG standard treatment and Allopurinol
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.
Group Type
ACTIVE_COMPARATOR
Allopurinol
Intervention Type
DRUG
Allopurinol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Allopurinol
Allopurinol
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Alloril
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Acute Coronary Syndrome with positive troponin
2. Patients with known or newly diagnosed diabetes mellitus with HbA1c above 7% and below 10%
3. Patients above the age of 40
4. Stable Hemodynamic state (At least 12 hours from presentation with acute coronary syndrome)
5. Uric Acid \> 6mg/dl or 355 micromol/l (males) and \>5mg/dl or 297 Micromol/l (females)
2. Patients with known or newly diagnosed diabetes mellitus with HbA1c above 7% and below 10%
3. Patients above the age of 40
4. Stable Hemodynamic state (At least 12 hours from presentation with acute coronary syndrome)
5. Uric Acid \> 6mg/dl or 355 micromol/l (males) and \>5mg/dl or 297 Micromol/l (females)
Exclusion Criteria
1. HbA1c below 7% or above 10%
2. Severe valvular insufficiency/Stenosis
3. Major surgery within 30 days
4. Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
5. Known intolerance/ current use of allopurinol/colchicine
6. Chronic inflammatory diseases: e.g. Lupus, rheumatoid arthritis, etc.
7. Current treatment with steroids, NSAID, chemotherapy or biologic medications
8. Extra-cardiac illness that is expected to limit survival to less than 2 years.
9. Past Cancer within the past 5 years (excluding BCC and SCC).
\-
2. Severe valvular insufficiency/Stenosis
3. Major surgery within 30 days
4. Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
5. Known intolerance/ current use of allopurinol/colchicine
6. Chronic inflammatory diseases: e.g. Lupus, rheumatoid arthritis, etc.
7. Current treatment with steroids, NSAID, chemotherapy or biologic medications
8. Extra-cardiac illness that is expected to limit survival to less than 2 years.
9. Past Cancer within the past 5 years (excluding BCC and SCC).
\-
Minimum Eligible Age
40 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
michal roll
Director. Research & development, Tel-Aviv Sourasky Medical Center
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yaron Arbel, M.D
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv University
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
Reference Type
BACKGROUND
Duckworth 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.
Reference Type
BACKGROUND
ACCORD 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.
Reference Type
BACKGROUND
BARI 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.
Reference Type
BACKGROUND
Look 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.
Reference Type
BACKGROUND
Arbel 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.
Reference Type
BACKGROUND
de 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.
Reference Type
BACKGROUND
Yang 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.
Reference Type
BACKGROUND
Neogi 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.
Reference Type
BACKGROUND
Richette 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.
Reference Type
BACKGROUND
Jia 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.
Reference Type
BACKGROUND
Baena 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.
Reference Type
BACKGROUND
Puddu 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.
Reference Type
BACKGROUND
Gotsman 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.
Reference Type
BACKGROUND
Miyaoka 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.
Reference Type
BACKGROUND
Wu AH, Ghali JK, Neuberg GW, O'Connor CM, Carson PE, Levy WC. Uric acid level and allopurinol use as risk markers of mortality and morbidity in systolic heart failure. Am Heart J. 2010 Nov;160(5):928-33. doi: 10.1016/j.ahj.2010.08.006.
Reference Type
BACKGROUND
Ito H, Abe M, Mifune M, Oshikiri K, Antoku S, Takeuchi Y, Togane M. Hyperuricemia is independently associated with coronary heart disease and renal dysfunction in patients with type 2 diabetes mellitus. PLoS One. 2011;6(11):e27817. doi: 10.1371/journal.pone.0027817. Epub 2011 Nov 18.
Reference Type
BACKGROUND
Takagi H, Umemoto T. Atorvastatin therapy reduces serum uric acid levels: a meta-analysis of randomized controlled trials. Int J Cardiol. 2012 May 31;157(2):255-7. doi: 10.1016/j.ijcard.2012.01.092. Epub 2012 Feb 21. No abstract available.
Reference Type
BACKGROUND
Kanbay M, Segal M, Afsar B, Kang DH, Rodriguez-Iturbe B, Johnson RJ. The role of uric acid in the pathogenesis of human cardiovascular disease. Heart. 2013 Jun;99(11):759-66. doi: 10.1136/heartjnl-2012-302535. Epub 2013 Jan 23.
Reference Type
BACKGROUND
Fan Y, Wei F, Lang Y, Wang S. Losartan treatment for hypertensive patients with hyperuricaemia in Chinese population: a meta-analysis. J Hypertens. 2015 Apr;33(4):681-8; discussion 689. doi: 10.1097/HJH.0000000000000478.
Reference Type
BACKGROUND
El-Bassossy HM, Watson ML. Xanthine oxidase inhibition alleviates the cardiac complications of insulin resistance: effect on low grade inflammation and the angiotensin system. J Transl Med. 2015 Mar 6;13:82. doi: 10.1186/s12967-015-0445-9.
Reference Type
BACKGROUND
Erdogan D, Tayyar S, Uysal BA, Icli A, Karabacak M, Ozaydin M, Dogan A. Effects of allopurinol on coronary microvascular and left ventricular function in patients with idiopathic dilated cardiomyopathy. Can J Cardiol. 2012 Nov-Dec;28(6):721-7. doi: 10.1016/j.cjca.2012.04.005. Epub 2012 Jun 19.
Reference Type
BACKGROUND
Rekhraj S, Gandy SJ, Szwejkowski BR, Nadir MA, Noman A, Houston JG, Lang CC, George J, Struthers AD. High-dose allopurinol reduces left ventricular mass in patients with ischemic heart disease. J Am Coll Cardiol. 2013 Mar 5;61(9):926-32. doi: 10.1016/j.jacc.2012.09.066.
Reference Type
BACKGROUND
Thanassoulis G, Brophy JM, Richard H, Pilote L. Gout, allopurinol use, and heart failure outcomes. Arch Intern Med. 2010 Aug 9;170(15):1358-64. doi: 10.1001/archinternmed.2010.198.
Reference Type
BACKGROUND
de Abajo FJ, Gil MJ, Rodriguez A, Garcia-Poza P, Alvarez A, Bryant V, Garcia-Rodriguez LA. Allopurinol use and risk of non-fatal acute myocardial infarction. Heart. 2015 May;101(9):679-85. doi: 10.1136/heartjnl-2014-306670. Epub 2015 Jan 5.
Reference Type
BACKGROUND
Grimaldi-Bensouda L, Alperovitch A, Aubrun E, Danchin N, Rossignol M, Abenhaim L, Richette P; PGRx MI Group. Impact of allopurinol on risk of myocardial infarction. Ann Rheum Dis. 2015 May;74(5):836-42. doi: 10.1136/annrheumdis-2012-202972. Epub 2014 Jan 6.
Reference Type
BACKGROUND
Struthers A, Shearer F. Allopurinol: novel indications in cardiovascular disease. Heart. 2012 Nov;98(21):1543-5. doi: 10.1136/heartjnl-2012-302249. Epub 2012 Jul 16. No abstract available.
Reference Type
BACKGROUND
Rentoukas E, Tsarouhas K, Tsitsimpikou C, Lazaros G, Deftereos S, Vavetsi S. The prognostic impact of allopurinol in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention. Int J Cardiol. 2010 Nov 19;145(2):257-258. doi: 10.1016/j.ijcard.2009.08.037. Epub 2009 Sep 22.
Reference Type
BACKGROUND
Givertz MM, Anstrom KJ, Redfield MM, Deswal A, Haddad H, Butler J, Tang WH, Dunlap ME, LeWinter MM, Mann DL, Felker GM, O'Connor CM, Goldsmith SR, Ofili EO, Saltzberg MT, Margulies KB, Cappola TP, Konstam MA, Semigran MJ, McNulty SE, Lee KL, Shah MR, Hernandez AF; NHLBI Heart Failure Clinical Research Network. Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study. Circulation. 2015 May 19;131(20):1763-71. doi: 10.1161/CIRCULATIONAHA.114.014536. Epub 2015 Apr 14.
Reference Type
BACKGROUND
Higgins P, Walters MR, Murray HM, McArthur K, McConnachie A, Lees KR, Dawson J. Allopurinol reduces brachial and central blood pressure, and carotid intima-media thickness progression after ischaemic stroke and transient ischaemic attack: a randomised controlled trial. Heart. 2014 Jul;100(14):1085-92. doi: 10.1136/heartjnl-2014-305683. Epub 2014 May 1.
Reference Type
BACKGROUND
Kao MP, Ang DS, Gandy SJ, Nadir MA, Houston JG, Lang CC, Struthers AD. Allopurinol benefits left ventricular mass and endothelial dysfunction in chronic kidney disease. J Am Soc Nephrol. 2011 Jul;22(7):1382-9. doi: 10.1681/ASN.2010111185. Epub 2011 Jun 30.
Reference Type
BACKGROUND
Erol T, Tekin A, Katircibasi MT, Sezgin N, Bilgi M, Tekin G, Zumrutdal A, Sezgin AT, Muderrisoglu H. Efficacy of allopurinol pretreatment for prevention of contrast-induced nephropathy: a randomized controlled trial. Int J Cardiol. 2013 Aug 20;167(4):1396-9. doi: 10.1016/j.ijcard.2012.04.068. Epub 2012 May 8.
Reference Type
BACKGROUND
Goicoechea M, Garcia de Vinuesa S, Verdalles U, Verde E, Macias N, Santos A, Perez de Jose A, Cedeno S, Linares T, Luno J. Allopurinol and progression of CKD and cardiovascular events: long-term follow-up of a randomized clinical trial. Am J Kidney Dis. 2015 Apr;65(4):543-9. doi: 10.1053/j.ajkd.2014.11.016. Epub 2015 Jan 13.
Reference Type
BACKGROUND
Noman A, Ang DS, Ogston S, Lang CC, Struthers AD. Effect of high-dose allopurinol on exercise in patients with chronic stable angina: a randomised, placebo controlled crossover trial. Lancet. 2010 Jun 19;375(9732):2161-7. doi: 10.1016/S0140-6736(10)60391-1. Epub 2010 Jun 9.
Reference Type
BACKGROUND
Guedes M, Esperanca A, Pereira AC, Rego C. What is the effect on cardiovascular events of reducing hyperuricemia with allopurinol? An evidence-based review. Rev Port Cardiol. 2014 Nov;33(11):727-32. doi: 10.1016/j.repc.2014.06.002. Epub 2014 Nov 20. English, Portuguese.
Reference Type
BACKGROUND
Castrejon I, Toledano E, Rosario MP, Loza E, Perez-Ruiz F, Carmona L. Safety of allopurinol compared with other urate-lowering drugs in patients with gout: a systematic review and meta-analysis. Rheumatol Int. 2015 Jul;35(7):1127-37. doi: 10.1007/s00296-014-3189-6. Epub 2014 Dec 18.
Reference Type
BACKGROUND
Kydd AS, Seth R, Buchbinder R, Falzon L, Edwards CJ, van der Heijde DM, Bombardier C. Urate-lowering therapy for the management of gout: a summary of 2 Cochrane reviews. J Rheumatol Suppl. 2014 Sep;92:33-41. doi: 10.3899/jrheum.140460.
Reference Type
BACKGROUND
Seth R, Kydd AS, Buchbinder R, Bombardier C, Edwards CJ. Allopurinol for chronic gout. Cochrane Database Syst Rev. 2014 Oct 14;2014(10):CD006077. doi: 10.1002/14651858.CD006077.pub3.
Reference Type
BACKGROUND
Spina M, Nagy Z, Ribera JM, Federico M, Aurer I, Jordan K, Borsaru G, Pristupa AS, Bosi A, Grosicki S, Glushko NL, Ristic D, Jakucs J, Montesinos P, Mayer J, Rego EM, Baldini S, Scartoni S, Capriati A, Maggi CA, Simonelli C; FLORENCE Study Group. FLORENCE: a randomized, double-blind, phase III pivotal study of febuxostat versus allopurinol for the prevention of tumor lysis syndrome (TLS) in patients with hematologic malignancies at intermediate to high TLS risk. Ann Oncol. 2015 Oct;26(10):2155-61. doi: 10.1093/annonc/mdv317. Epub 2015 Jul 27.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TASMC-18-YA-354-18-CTIL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Early Aortic Valve Lipoprotein(a) Lowering Trial
NCT02109614
WITHDRAWN
EARLY_PHASE1
SB-480848 In Subjects With Coronary Heart Disease
NCT00269048
COMPLETED
PHASE2
Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD
NCT01754259
COMPLETED
PHASE3
Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease
NCT01604213
COMPLETED
PHASE4
The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
NCT00407771
UNKNOWN
PHASE4
The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes
NCT01165983
COMPLETED
NA
Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization
NCT00438867
UNKNOWN
PHASE3
A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
NCT01715818
COMPLETED
PHASE3
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
NCT07157774
RECRUITING
PHASE3
Aliskiren Effect on Aortic Plaque Progression
NCT01417104
TERMINATED
PHASE2/PHASE3
The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers
NCT00494559
COMPLETED
PHASE4
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
NCT01106534
COMPLETED
PHASE4
A Proof of Concept Study to Determine the Local Delivery and Efficacy of Nanocort
NCT01647685
UNKNOWN
PHASE1/PHASE2
Silencing Inflammatory Activity by Injecting Nanocort in Patients at Risk for Atherosclerotic Disease
NCT01601106
UNKNOWN
PHASE1/PHASE2
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
NCT05646381
RECRUITING
PHASE2
CER-001 Atherosclerosis Regression ACS Trial
NCT02484378
COMPLETED
PHASE2
Treatment of Patients With Atherosclerotic Disease With Paclitaxel-associated to LDL Like Nanoparticles
NCT04148833
UNKNOWN
PHASE2/PHASE3
Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)
NCT00346437
COMPLETED
PHASE2/PHASE3
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
NCT06572267
RECRUITING
PHASE2
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
NCT07102628
RECRUITING
PHASE3
Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
NCT03004638
COMPLETED
PHASE2
A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack
NCT07301034
RECRUITING
PHASE3
Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
NCT01806077
COMPLETED
PHASE1
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
NCT01612884
TERMINATED
PHASE4