Allopurinol and Endothelial Function in Diabetic CAD Patients

Coronary Artery Disease Clinical Trial

— ALLIENCE  

Official title:

Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03385135
• Other study ID #: ALLIENCE
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2017
• Last updated: December 26, 2017
• Start date: December 2017
• Est. completion date: June 2018

Study information

• Verified date: December 2017
• Source: University Tunis El Manar
• Contact: Sami Kasbaoui, MD
• Phone: +21622560059
• Email: kas.sami77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized trial assessing the impact of allopurinol on endothelial function in optimally treated diabetic patients with coronary artery disease. After initial screening, subjects were randomized to receive either optimal medical therapy (OMT) + allopurinol or OMT alone for 8 weeks. The dose of allopurinol was 300 mg for 4 weeks and 600 mg for 4 weeks with a 4-weekly check on hematology and biochemistry

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes type 2

• Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month

Exclusion Criteria:

• Pregnant or breast- feeding women

• creatinine clearance <60ml/min

• Known history of gout disease or ongoing treatment with allopurinol

• Allergy to allopurinol

• Inability to provide informed consent

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Drug:
• Allopurinol
300 mg for 4 weeks then 600 mg for 4 weeks in the active group

Locations

Country	Name	City	State
Tunisia	Cardiology Department, Abderrahmen Mami Hospital	Ariana

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelium-dependent vasodilation	Brachial Artery Flow-Mediated dilation (FMD)	2 months
Secondary	Endothelium-independent vasodilation	Changes in brachial artery diameter in response to nitrates	2 months
Secondary	Quality of Life (QoL)	Seattle Angina Questionnaire: a scale that quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	2 months
Secondary	Major adverse cardiac events (MACE)	composite of cardiac death, non fatal myocardial infarction and unplanned coronary revascularization	2 months