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

Phase 4

• Conditions: Diabetes Mellitus Type 2 Platelets Reactivity Statin
• Interventions: Drug: Atorvastatin 80mg; Drug: ALLOPURINOL 300 MG; Drug: Atorvastatin 80mg AND allopurinol 300 mg

• Registration Number: NCT03195153
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-28
• Study First Submitted: 2017-05-28
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Study First Posted: 2017-06-22
• Last Update Posted: 2017-06-22
• Primary Completion: 2017-06-23
• Study Completion: 2017-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
statin only	Atorvastatin 80mg	30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)
allopurinol only	ALLOPURINOL 300 MG	30 DAYS OF ALLOPURINOL (300 MG)
statin and allopurinol	Atorvastatin 80mg AND allopurinol 300 mg	30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL

Primary Outcome Measures

Name	Time	Method
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	fter 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 \[Accumetrics, San Diego, California\]

Trial Locations

Locations (1)

Policlinico Umberto I; 🇮🇹 Rome, Roma, Italy