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

NCT03195153 | Unknown Phase 4

• 1 other identifier: UNIVERSITY OF ROME
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2 Platelets Reactivity Statin

Outcome Measures

Primary Outcomes (1)

• 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 \[Accumetrics, San Diego, California\]

  fter 30 days of treatment with each drug

Study Arms (3)

statin only

EXPERIMENTAL

30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)

Drug: Atorvastatin 80mg

allopurinol only

EXPERIMENTAL

30 DAYS OF ALLOPURINOL (300 MG)

Drug: ALLOPURINOL 300 MG

statin and allopurinol

EXPERIMENTAL

30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL

Drug: Atorvastatin 80mg AND allopurinol 300 mg

Interventions

Atorvastatin 80mg DRUG

30 DAYS OF atorvastatin 80 mg

statin only

ALLOPURINOL 300 MG DRUG

30 DAYS OF ALLOPURINOL 300 MG

allopurinol only

Atorvastatin 80mg AND allopurinol 300 mg DRUG

30 days of atorvastatin and allopurinol 300 mg

statin and allopurinol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, Roma, 00155, Italy

RECRUITING

MeSH Terms

Interventions

Atorvastatin; Allopurinol

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

marina mp polacco

CONTACT

3333347960; polamari@libero.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, principal investigator

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 22, 2017
• Study Start: March 28, 2017
• Primary Completion: June 23, 2017
• Study Completion: July 15, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

IT (1)