Allopurinol and Endothelial Function in Diabetic CAD Patients

Study Overview
=================
Brief 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

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

Conditions
-----------------
Diabetes Mellitus, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allopurinol group<br>Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks | Drug: Allopurinol<br>* 300 mg for 4 weeks then 600 mg for 4 weeks in the active group<br>* Other names: Optimal Medical Therapy;|
| No Intervention: No Allopurinol group<br>Optimal medical therapy alone | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelium-dependent vasodilation | Brachial Artery Flow-Mediated dilation (FMD) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelium-independent vasodilation | Changes in brachial artery diameter in response to nitrates | 2 months | 
| 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 | 
| Major adverse cardiac events (MACE) | composite of cardiac death, non fatal myocardial infarction and unplanned coronary revascularization | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allopurinol, coronary artery disease, diabetes, endothelial function