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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

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ClinicalTrials.gov Identifier: NCT03195153
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Polacco Marina, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Platelets Reactivity Statin Drug: Atorvastatin 80mg Drug: ALLOPURINOL 300 MG Drug: Atorvastatin 80mg AND allopurinol 300 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : June 23, 2017
Estimated Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: statin only
30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)
Drug: Atorvastatin 80mg
30 DAYS OF atorvastatin 80 mg

Experimental: allopurinol only
30 DAYS OF ALLOPURINOL (300 MG)
Drug: ALLOPURINOL 300 MG
30 DAYS OF ALLOPURINOL 300 MG

Experimental: statin and allopurinol
30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL
Drug: Atorvastatin 80mg AND allopurinol 300 mg
30 days of atorvastatin and allopurinol 300 mg




Primary Outcome Measures :
  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 [ Time Frame: 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]



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195153


Contacts
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Contact: marina mp polacco 3333347960 polamari@libero.it

Locations
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Italy
Policlinico Umberto I Recruiting
Rome, Roma, Italy, 00155
Contact: MARINA MD POLACCO    3333347960    POLAMARI@LIBERO.IT   
Sponsors and Collaborators
University of Roma La Sapienza

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Responsible Party: Polacco Marina, MD, principal investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03195153     History of Changes
Other Study ID Numbers: UNIVERSITY OF ROME
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

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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

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Allopurinol
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Gout Suppressants
Free Radical Scavengers