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

This study is currently recruiting participants.
Verified October 2012 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor:
Collaborator:
Andaluz Health Service
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01684813
First received: September 11, 2012
Last updated: February 27, 2013
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type II
Acute Coronary Syndrome
 Drug: Prasugrel.
Drug: Clopidogrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study With Loading Dose of Prasugrel Opposed to the Standard Dose of Clopidogrel in Type 2 Diabetic Patients in Acute Coronary Syndrome, Revascularized Through Drug-eluting Stent.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • Number of patients who achieve inhibition of platelet aggregation greater that 50% [ Time Frame: 24 to 36 hours post-PCI ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To evaluate the safety of treatment with prasugrel in comparison with the standard treatment with clopidogrel in terms of the appearance of secondary effects (severe bleeding, thrombocytopenia, neutropenia, gastrointestinal changes, thrombotic thrombocytopenic purpura).

  • Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy. [ Time Frame: 30 days. ] [ Designated as safety issue: Yes ]
    To assess the results in different sub-groups and analyze the combined endpoint of cardiovascular death, MI or recurrent ischemia at 30 days.

  • Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy [ Time Frame: 30 days. ] [ Designated as safety issue: No ]
    To analyze the characteristics of patients who are non-responsive to anti-aggregation therapy.


Estimated Enrollment: 65
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clopidogrel
This group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg.
 Drug: Clopidogrel
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.
Other Name: Agrelan
Experimental: Prasugrel
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.
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.
Other Name: Efient, Eli Lilly

Detailed Description:

The VERDI study consists on a randomized, mono-center study comparing the treatment plan of a loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with a stent. The aim 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized.
  3. Participants must sign an informed consent document.

Exclusion Criteria:

  1. Age <18 years or >80 years.
  2. Patients with acute coronary syndrome with ST segment elevation.
  3. Pregnancy previous to or during the study.
  4. 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).
  5. Antithrombotic treatment with GP IIb/IIIa inhibitors.

  6. 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.
  7. 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.
  8. Patients with previous TIA or CVA.
  9. Patients weighing <60 Kg.
  10. Hemoglobin <10.5 g/dl, or Hematocrit <30%.
  11. Severe left ventricular systolic dysfunction, EF <35%.
  12. Renal insufficiency with creatinine levels >2 mg/dl.
  13. Previous inclusion of the patient in another study.
  14. Treatment in research (medication or device) in the last 30 days prior.
  15. Medical, geographical, or social factors that would make participation in the study impractical, such as the incapacity to provide written informed consent and to understand the complete meaning of informed consent, or the refusal of the patient to participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684813

Contacts
Contact: Jose María Cubero Gómez, MD +34955012358 juan.acostamartinez@yahoo.es
Contact: Clara Rosso, MD +34955013414 claram.rosso.sspa@juntadeandalucia.es

Locations
Spain
Hospital Universitario Virgen del Rocío Recruiting
Seville, Spain, 41013
Contact: Jose María Cubero Gómez, MD     955012358 ext 0034     juan.acostamartinez@yahoo.es    
Principal Investigator: Jose María Cubero Gómez, MD            
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Andaluz Health Service
  More Information

No publications provided

Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01684813     History of Changes
Other Study ID Numbers: VERDI study
Study First Received: September 11, 2012
Last Updated: February 27, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Diabetes mellitus.
Acute coronary syndrome.
Percutaneous coronary intervention.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
 Ticlopidine
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on May 22, 2013