Allopurinol and Endothelial Function in Diabetic CAD Patients (ALLIENCE)

December 26, 2017 updated by: Kasbaoui sami, University Tunis El Manar

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Ariana, Tunisia, 2008
        • Recruiting
        • Cardiology Department, Abderrahmen Mami Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Allopurinol group
Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks
Drug: Allopurinol
300 mg for 4 weeks then 600 mg for 4 weeks in the active group
Other Names:
  • Optimal Medical Therapy
No Intervention: No Allopurinol group
Optimal medical therapy alone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

Investigators

  • Study Chair: Salem Kachboura, MD, Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

December 26, 2017

First Posted (Actual)

December 28, 2017

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 26, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLIENCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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