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Allopurinol and Endothelial Function in Diabetic CAD Patients

NCT ID: NCT03385135

Last Updated: 2017-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Diabetes Mellitus Coronary Artery Disease

Keywords

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allopurinol coronary artery disease diabetes endothelial function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Allopurinol group

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

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

300 mg for 4 weeks then 600 mg for 4 weeks in the active group

No Allopurinol group

Optimal medical therapy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Allopurinol

300 mg for 4 weeks then 600 mg for 4 weeks in the active group

Intervention Type DRUG

Other Intervention Names

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Optimal Medical Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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Kasbaoui sami

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salem Kachboura, MD

Role: STUDY_CHAIR

Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana

Locations

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Cardiology Department, Abderrahmen Mami Hospital

Aryanah, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Sami Kasbaoui, MD

Role: CONTACT

Phone: +21622560059

Email: [email protected]

Marouane Boukhris, MD

Role: CONTACT

Phone: +21622557125

Email: [email protected]

Facility Contacts

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Sami Kasbaoui, MD

Role: primary

Marouane Boukhris, MD

Role: backup

Other Identifiers

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ALLIENCE

Identifier Type: -

Identifier Source: org_study_id