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Allopurinol in Diabetes Mellitus and Multivessel Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700645
Recruitment Status : Unknown
Verified November 2018 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief 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.

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).


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Ischemic Heart Disease Multi Vessel Coronary Artery Disease Drug: Allopurinol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Allopurinol in the Treatment of Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease Treated by Either PCI or CABG: Pilot Study
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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.
Drug: Allopurinol
Allopurinol
Other Name: Alloril

No Intervention: 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.
Active Comparator: 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.
Drug: Allopurinol
Allopurinol
Other Name: Alloril




Primary Outcome Measures :
  1. hs-CRP [ Time Frame: 3 months. ]
    Change in inflammatory biomarkers


Secondary Outcome Measures :
  1. hs-CRP [ Time Frame: one month ]
    Change in inflammatory biomarkers

  2. Endothelial function markers [ Time Frame: 3 month ]
    Endothelin-1, I-CAM, V-CAM, superoxide dismutase ADMA, and oxidized LDL, Change of RH-PAT

  3. Heart rate variability [ Time Frame: 3 month ]
    Heart rate variability

  4. functional status and quality of life: the Seattle angina questionnaire [ Time Frame: 3 month ]
    Quality of life evaluation- evaluates functional limitation in different activities due to chest pain and angina

  5. Uric acid levels [ Time Frame: one month and 3 month ]
    Uric acid levels

  6. functional status, quality of life: EuroQol EQ-5D questionnaire [ Time Frame: 3 month ]
    evaluation of degree of limitation in different daily activities

  7. Reduction of peri-procedural myocardial infarction [ Time Frame: 72 hours ]
    Reduction of peri-procedural myocardial infarction

  8. MACE [ Time Frame: 3 month ]
    major adverse cardiac events

  9. Diastolic function [ Time Frame: 3 month ]
    Diastolic function per echocardiogram- E/A

  10. Diastolic function [ Time Frame: 3 month ]
    Diastolic function per echocardiogram-E/E' med

  11. Diastolic function [ Time Frame: 3 month ]
    Diastolic function per echocardiogram- E/E' lat

  12. Diastolic function [ Time Frame: 3 month ]
    Diastolic function per echocardiogram- DT time



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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).

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700645


Contacts
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Contact: Natalia Kofman, M.D 97239673222 natalia.kofman@gmail.com
Contact: Yaron Arbel, M.D 97236973222 yarona@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Yaron Arbel, M.D Tel Aviv University
Publications:

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Responsible Party: michal roll, Director. Research & development, Tel-Aviv Sourasky Medical Center, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03700645    
Other Study ID Numbers: TASMC-18-YA-354-18-CTIL
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
Diabetes Mellitus
Uric asid
Multi Vessel Coronary Artery Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs