Allopurinol and Endothelial Function in Diabetic CAD Patients (ALLIENCE)

University Tunis El Manar

Status: Unknown

Conditions: Coronary Artery Disease; Diabetes Mellitus

Treatments: Drug: Allopurinol

Study type: Interventional

Funder types: Other

Identifiers

NCT03385135

ALLIENCE

Details and patient eligibility

About

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

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

58 participants in 2 patient groups

Allopurinol group

Active Comparator group

Description:

Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks

Treatment:

Drug: Allopurinol

No Allopurinol group

No Intervention group

Description:

Optimal medical therapy alone