Overview

Allopurinol in Diabetes Mellitus and Multivessel Coronary Artery Disease

Status:
Unknown status
Trial end date:
2020-01-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Treatments:
Allopurinol
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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