VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel

NCT01684813 | Completed Phase 4

• 1 other identifier: VERDI study
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.

Conditions

Diabetes Mellitus Type II; Acute Coronary Syndrome

Keywords

Diabetes mellitus.; Acute coronary syndrome.; Percutaneous coronary intervention.

Outcome Measures

Primary Outcomes (1)

• Number of patients who achieve inhibition of platelet aggregation greater that 50%

  The principal objective is to determine whether in type 2 diabetic patients who are non-responsive to clopidogrel at habitual doses and who receive treatment through percutaneous coronary intervention (PCI) with a stent, a treatment plan with a loading dose of prasugrel (60 mg) followed by 1 cp (10 mg) once a day, is superior to a standard dose of 75 mg clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.

  24 to 36 hours post-PCI

Secondary Outcomes (3)

• Number of participants with adverse events as a measure of safety and tolerability

  30 days

• Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.

  30 days.

• Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy

  30 days.

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

This group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg.

Drug: Clopidogrel

Prasugrel

EXPERIMENTAL

This group will receive after PCI a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by a daily dose of prasugrel (10 mg tablet).

Drug: Prasugrel.

Interventions

Prasugrel. DRUG

Patients in this group will receive a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by at least dose of 10 mg prasugrel (1 x 10 mg tablet). Beyond the second day after PCI, these patients will receive double antiaggregation therapy according to their physician´s criteria.

Also known as: Efient, Eli Lilly

Prasugrel

Clopidogrel DRUG

Patients in this group will receive the standard dose of clopidogrel, a daily dose of 75 mg. Beyond the second day post-PCI, these patients will receive double anti aggregation therapy according to their physician's criteria.

Also known as: Agrelan

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients with acute coronary syndrome with non-ST segment elevation who are undergoing a percutaneous coronary intervention (PCI) with a coronary stent.
• Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized.
• Participants must sign an informed consent document.

You may not qualify if:

• Age \<18 years or \>80 years.
• Patients with acute coronary syndrome with ST segment elevation.
• Pregnancy previous to or during the study.
• The use of oral anticoagulants in the last 10 days with an INR \>1.5 or who plan to use them during the follow-up period (1 year).
• Antithrombotic treatment with GP IIb/IIIa inhibitors.
• Contraindication for the use of prasugrel and/or clopidogrel and/or aspirin:
• Antecedents of pharmacologic allergy to thienopyridine derivatives or aspirin.
• Antecedents of clinically significant or persistent thrombocytopenia or neutropenia.
• Active bleeding or significant increase of risk of hemorrhage such as severe hepatic insufficiency, peptic ulcer present, proliferative diabetic retinopathy, antecedents of severe systemic bleeding, gastrointestinal bleeding, macrohematuria, intraocular hemorrhage, hemorrhagic stroke, or intracranial bleeding), or other antecedents of bleeding diathesis or coagulopathy.
• Patients with previous TIA or CVA.
• Patients weighing \<60 Kg.
• Hemoglobin \<10.5 g/dl, or Hematocrit \<30%.
• Severe left ventricular systolic dysfunction, EF \<35%.
• Renal insufficiency with creatinine levels \>2 mg/dl.
• Treatment in research (medication or device) in the last 30 days prior.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Andaluz Health Service: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Seville, 41013, Spain

Location

Related Publications (1)

• Cubero Gomez JM, Acosta Martinez J, Mendias Benitez C, Diaz De La Llera LS, Fernandez-Quero M, Guisado Rasco A, Villa Gil-Ortega M, Sanchez Gonzalez A. VERifyNow in DIabetes high-on-treatment platelet reactivity: a pharmacodynamic study on switching from clopidogrel to prasugrel. Acta Cardiol. 2015 Dec;70(6):728-34. doi: 10.2143/AC.70.6.3120187.

  PMID: 26717223 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Acute Coronary Syndrome; Diabetes Mellitus

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

ES (1)