Overview

Allopurinol in Patients With Refractory Angina to Improve Ischemic Symptoms

Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
Summary
Despite numerous advances in medical treatment and revascularization procedures for the treatment of patients with stable angina, debilitating symptoms that are unresponsive to conventional therapy may occur in patients unsuitable for revascularization, a condition known as refractory angina. Allopurinol, a methylxanthine oxidase inhibitor, is widely used in the treatment of gout and asymptomatic hyperuricemia. On the other hand, the anti-ischemic effects of allopurinol have been the subject of increasing interest. Therefore, the investigators will study the safety and efficacy of allopurinol in alleviating ischemic symptoms in patients with refractory angina already on optimal medical therapy.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ministry of Health, Brazil
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
InCor Heart Institute
Treatments:
Allopurinol
Criteria
Inclusion Criteria:

- Clinical diagnosis of stable angina in functional class (CCS) ≥ 2 for at least three
months in patients taking maximally tolerated doses of at least three classes of
antianginal agents

- Documentation of myocardial ischemia by any provocative functional test (exercise
test, stress echocardiogram, myocardial perfusion scintigraphy or cardiac resonance)

- Signature of the Informed Consent Form

Exclusion Criteria:

- Left ventricular dysfunction defined by LVEF < 30% on transthoracic echocardiogram

- Significant concomitant valve disease

- Chronic renal failure stage 4 or 5 (GFR < 30mL/min/1.73m2 calculated by the MDRD
equation

- Significant liver dysfunction (Child-Pugh class C) or MELD value ≥ 15 calculated from
creatinine, total bilirubin, and INR values

- Current use of warfarin

- Prior use of allopurinol within three months of randomization

- Pregnant and lactating women