Diabetes MellitusALLIENCENCT03385135
Allopurinol and Endothelial Function in Diabetic CAD Patients
A study testing Allopurinol in people with Diabetes Mellitus and Coronary Artery Disease, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Coronary Artery Disease
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTunisia
- Study dates
- Dec 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes type 2
- Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Cardiology Department, Abderrahmen Mami Hospital
Aryanah, 2008
Sami Kasbaoui, MD, +21622560059, kas.sami77@gmail.com
Marouane Boukhris, MD, +21622557125, mar1bou@hotmail.com
About this study
Official title: 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
- Conditions
- Diabetes Mellitus, Coronary Artery Disease
- Being tested
- Allopurinol
- Keywords
- allopurinol, coronary artery disease, diabetes, endothelial function
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Optimal Medical Therapy
300 mg for 4 weeks then 600 mg for 4 weeks in the active group
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol group | Active comparator | Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks Receives: Drug: Allopurinol |
| No Allopurinol group | No intervention | Optimal medical therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent vasodilation
Brachial Artery Flow-Mediated dilation (FMD)
Measured: 2 months
Secondary outcomes (3)
Endothelium-independent vasodilation
Changes in brachial artery diameter in response to nitrates
Measured: 2 months
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).
Measured: 2 months
Major adverse cardiac events (MACE)
composite of cardiac death, non fatal myocardial infarction and unplanned coronary revascularization
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasbaoui sami, University Tunis El Manar
- Investigators
- Salem Kachboura, MD, Study chair, Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385135
- Sponsor's protocol ID
- ALLIENCE
- Acronym
- ALLIENCE
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2017
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03385135
- Acronym / sponsor ID
- ALLIENCE / ALLIENCE
- Conditions
- Diabetes Mellitus, Coronary Artery Disease
- Keywords
- allopurinol, coronary artery disease, diabetes, endothelial function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol group | Active comparator | Drug: AllopurinolOptimal 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 intervention | –Optimal medical therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes type 2
- Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAlso: Optimal Medical Therapy300 mg for 4 weeks then 600 mg for 4 weeks in the active group | Drug | Allopurinol group |
Primary outcome
Endothelium-dependent vasodilation
Time frame: 2 months
Brachial Artery Flow-Mediated dilation (FMD)
3 secondary outcomes
Endothelium-independent vasodilation
Time frame: 2 months
Quality of Life (QoL)
Time frame: 2 months
Major adverse cardiac events (MACE)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salem Kachboura, MD study chair
Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allopurinol in people with Diabetes Mellitus and Coronary Artery Disease, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sami Kasbaoui, MD (+21622560059, kas.sami77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelium-dependent vasodilation (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.