Allopurinol and Endothelial Function in Diabetic CAD Patients (ALLIENCE)

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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Intervention / Treatment: Drug: Allopurinol

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Ariana, Tunisia, 2008
    • Recruiting
    • Cardiology Department, Abderrahmen Mami Hospital
    • Contact: Sami Kasbaoui, MD; Phone Number: +21622560059; Email: kas.sami77@gmail.com
    • Contact: Marouane Boukhris, MD; Phone Number: +21622557125; Email: mar1bou@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Study Chair: Salem Kachboura, MD, Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 26, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: diabetes; coronary artery disease; allopurinol; endothelial function
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: ALLIENCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No