- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03385135
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 Contact
- Name: Sami Kasbaoui, MD
- Phone Number: +21622560059
- Email: kas.sami77@gmail.com
Study Contact Backup
- Name: Marouane Boukhris, MD
- Phone Number: +21622557125
- Email: mar1bou@hotmail.com
Study Locations
-
-
-
Ariana, Tunisia, 2008
- Recruiting
- Cardiology Department, Abderrahmen Mami Hospital
-
Contact:
- Sami Kasbaoui, MD
- Phone Number: +21622560059
- Email: kas.sami77@gmail.com
-
Contact:
- Marouane Boukhris, MD
- Phone Number: +21622557125
- Email: mar1bou@hotmail.com
-
-
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
|
300 mg for 4 weeks then 600 mg for 4 weeks in the active group
Other Names:
|
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
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
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites
- Protective Agents
- Antioxidants
- Free Radical Scavengers
- Gout Suppressants
- Allopurinol
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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