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Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin

Primary Purpose

Diabetes Mellitus Type 2 Platelets Reactivity Statin

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Atorvastatin 80mg
ALLOPURINOL 300 MG
Atorvastatin 80mg AND allopurinol 300 mg
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 Platelets Reactivity Statin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diabetic patient;
  • therapy with aspirin and insulin;
  • patient well responders

Exclusion Criteria:

  • not diabetic patient;
  • patients in dual antiplatelet therapy;
  • patient with severe renal failure;
  • patient poor responders

Sites / Locations

  • Policlinico Umberto IRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

statin only

allopurinol only

statin and allopurinol

Arm Description

30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)

30 DAYS OF ALLOPURINOL (300 MG)

30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL

Outcomes

Primary Outcome Measures

Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]

Secondary Outcome Measures

Full Information

First Posted
May 28, 2017
Last Updated
June 19, 2017
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT03195153
Brief Title
Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin
Official Title
Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
June 23, 2017 (Anticipated)
Study Completion Date
July 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

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
No

5. Study Description

Brief Summary
Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial clinical and experimental evidence suggest that both diabetes and insulin resistance cause a combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular disease. It has been implicated as an independent risk factor for cardiovascular disease and premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as well as for patients with essential hypertension. A complete biochemical understanding of the mechanisms by which hyperglycemia causes vascular functional and structural changes associated with the diabetic milieu still eludes us. In recent years, the numerous biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of diabetic vascular disease have been distilled into several unifying hypotheses. The role of chronic hyperglycemia in the development of diabetic microvascular complications and in neuropathy has been clearly established. However, the biochemical or cellular links between elevated blood glucose levels, and the vascular lesions remain incompletely understood. A number of trials have demonstrated that statins therapy as well as angiotensin converting enzyme inhibitors is associated with improvements in endothelial function in diabetes. Although antioxidants provide short-term improvement of endothelial function in humans, all studies of the effectiveness of preventive antioxidant therapy have been disappointing. Actually, control of hyperglycemia thus remains the best way to improve endothelial function and to prevent atherosclerosis and other cardiovascular complications of diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 Platelets Reactivity Statin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
statin only
Arm Type
Experimental
Arm Description
30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)
Arm Title
allopurinol only
Arm Type
Experimental
Arm Description
30 DAYS OF ALLOPURINOL (300 MG)
Arm Title
statin and allopurinol
Arm Type
Experimental
Arm Description
30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Intervention Description
30 DAYS OF atorvastatin 80 mg
Intervention Type
Drug
Intervention Name(s)
ALLOPURINOL 300 MG
Intervention Description
30 DAYS OF ALLOPURINOL 300 MG
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg AND allopurinol 300 mg
Intervention Description
30 days of atorvastatin and allopurinol 300 mg
Primary Outcome Measure Information:
Title
Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug
Description
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]
Time Frame
fter 30 days of treatment with each drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diabetic patient; therapy with aspirin and insulin; patient well responders Exclusion Criteria: not diabetic patient; patients in dual antiplatelet therapy; patient with severe renal failure; patient poor responders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marina mp polacco
Phone
3333347960
Email
polamari@libero.it
Facility Information:
Facility Name
Policlinico Umberto I
City
Rome
State/Province
Roma
ZIP/Postal Code
00155
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARINA MD POLACCO
Phone
3333347960
Email
POLAMARI@LIBERO.IT

12. IPD Sharing Statement

Learn more about this trial

Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin

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