Allopurinol in Diabetes Mellitus and Multivessel Coronary Artery Disease

NCT03700645 | Unknown Phase 4

• 1 other identifier: TASMC-18-YA-354-18-CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes Mellitus; Ischemic Heart Disease; Multi Vessel Coronary Artery Disease

Keywords

Diabetes Mellitus; Uric asid; Multi Vessel Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• hs-CRP

  Change in inflammatory biomarkers

  3 months.

Secondary Outcomes (12)

• hs-CRP

  one month

• Endothelial function markers

  3 month

• Heart rate variability

  3 month

• functional status and quality of life: the Seattle angina questionnaire

  3 month

• Uric acid levels

  one month and 3 month

Study Arms (4)

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.

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.

Drug: Allopurinol

Interventions

Allopurinol DRUG

Allopurinol

Also known as: Alloril

CABG standard treatment and Allopurinol; PCI, standard treatment and Allopurinol

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

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MeSH Terms

Conditions

Diabetes Mellitus; Myocardial Ischemia

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yaron Arbel, M.D

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Kofman, M.D

CONTACT

97239673222; natalia.kofman@gmail.com

Yaron Arbel, M.D

CONTACT

97236973222; yarona@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director. Research & development, Tel-Aviv Sourasky Medical Center

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: October 9, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share