Allopurinol and Endothelial Function in Diabetic CAD Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT03385135
• Date of registration: 14/12/2017
• Prospective Registration: No
• Primary sponsor: University Tunis El Manar
• Public title: Allopurinol and Endothelial Function in Diabetic CAD Patients ALLIENCE
• Scientific title: Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease
• Date of first enrolment: December 2017
• Target sample size: 58
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03385135
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Tunisia

Contacts

• Name: Sami Kasbaoui, MD

• Name: Salem Kachboura, MD
• Affiliation: Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana

• Name: Sami Kasbaoui, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Diabetes Mellitus

Intervention(s)

Drug: Allopurinol

Primary Outcome(s)

Endothelium-dependent vasodilation [Time Frame: 2 months]

Secondary Outcome(s)

Quality of Life (QoL) [Time Frame: 2 months]

Major adverse cardiac events (MACE) [Time Frame: 2 months]

Endothelium-independent vasodilation [Time Frame: 2 months]

Secondary ID(s)

ALLIENCE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors