Allopurinol and Endothelial Function in Diabetic CAD Patients

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03385135

Acronym

ALLIENCE

Enrollment

Registered

2017-12-28

Start date

2017-12-31

Completion date

2018-06-30

Last updated

2017-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Diabetes Mellitus

Keywords

allopurinol, coronary artery disease, diabetes, endothelial function

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

Interventions

DRUGAllopurinol

300 mg for 4 weeks then 600 mg for 4 weeks in the active group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Tunisia

Contacts

Primary ContactSami Kasbaoui, MD

kas.sami77@gmail.com+21622560059

Backup ContactMarouane Boukhris, MD

mar1bou@hotmail.com+21622557125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026