Status:
UNKNOWN
Allopurinol in Patients With Refractory Angina to Improve Ischemic Symptoms
Lead Sponsor:
Ministry of Health, Brazil
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
InCor Heart Institute
Conditions:
Refractory Angina
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ma...
Detailed Description
One of the most common clinical presentations associated with coronary artery disease (CAD) is stable angina, which can be translated clinically into chest discomfort (or equivalent) evoked by differe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04368819
Start Date
March 3 2021
End Date
December 31 2021
Last Update
February 24 2021
Active Locations (1)
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1
Heart Institute
São Paulo, São Paulo, Brazil, 05403-000