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Allopurinol and Endothelial Function in Diabetic CAD Patients (ALLIENCE)

Primary Purpose

Diabetes Mellitus, Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Allopurinol
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring allopurinol, coronary artery disease, diabetes, endothelial function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiology Department, Abderrahmen Mami HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Allopurinol group

No Allopurinol group

Arm Description

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

Optimal medical therapy alone

Outcomes

Primary Outcome Measures

Endothelium-dependent vasodilation
Brachial Artery Flow-Mediated dilation (FMD)

Secondary Outcome Measures

Endothelium-independent vasodilation
Changes in brachial artery diameter in response to nitrates
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).
Major adverse cardiac events (MACE)
composite of cardiac death, non fatal myocardial infarction and unplanned coronary revascularization

Full Information

First Posted
December 14, 2017
Last Updated
December 26, 2017
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT03385135
Brief Title
Allopurinol and Endothelial Function in Diabetic CAD Patients
Acronym
ALLIENCE
Official Title
Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Coronary Artery Disease
Keywords
allopurinol, coronary artery disease, diabetes, endothelial function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol group
Arm Type
Active Comparator
Arm Description
Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks
Arm Title
No Allopurinol group
Arm Type
No Intervention
Arm Description
Optimal medical therapy alone
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
Optimal Medical Therapy
Intervention Description
300 mg for 4 weeks then 600 mg for 4 weeks in the active group
Primary Outcome Measure Information:
Title
Endothelium-dependent vasodilation
Description
Brachial Artery Flow-Mediated dilation (FMD)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Endothelium-independent vasodilation
Description
Changes in brachial artery diameter in response to nitrates
Time Frame
2 months
Title
Quality of Life (QoL)
Description
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).
Time Frame
2 months
Title
Major adverse cardiac events (MACE)
Description
composite of cardiac death, non fatal myocardial infarction and unplanned coronary revascularization
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sami Kasbaoui, MD
Phone
+21622560059
Email
kas.sami77@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marouane Boukhris, MD
Phone
+21622557125
Email
mar1bou@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salem Kachboura, MD
Organizational Affiliation
Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiology Department, Abderrahmen Mami Hospital
City
Ariana
ZIP/Postal Code
2008
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sami Kasbaoui, MD
Phone
+21622560059
Email
kas.sami77@gmail.com
First Name & Middle Initial & Last Name & Degree
Marouane Boukhris, MD
Phone
+21622557125
Email
mar1bou@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Allopurinol and Endothelial Function in Diabetic CAD Patients

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