Allopurinol and Endothelial Function in Diabetic CAD Patients
ALLIENCE
Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease
1 other identifier
interventional
58
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Dec 2017
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedDecember 28, 2017
December 1, 2017
3 months
December 14, 2017
December 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelium-dependent vasodilation
Brachial Artery Flow-Mediated dilation (FMD)
2 months
Secondary Outcomes (3)
Endothelium-independent vasodilation
2 months
Quality of Life (QoL)
2 months
Major adverse cardiac events (MACE)
2 months
Study Arms (2)
Allopurinol group
ACTIVE COMPARATOROptimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks
No Allopurinol group
NO INTERVENTIONOptimal medical therapy alone
Interventions
300 mg for 4 weeks then 600 mg for 4 weeks in the active group
Eligibility Criteria
You may qualify if:
- Diabetes type 2
- Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology Department, Abderrahmen Mami Hospital
Aryanah, 2008, Tunisia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Salem Kachboura, MD
Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 14, 2017
First Posted
December 28, 2017
Study Start
December 1, 2017
Primary Completion
March 1, 2018
Study Completion
June 1, 2018
Last Updated
December 28, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL