Clinical trial NCT01684813: VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus Type II
Acute Coronary Syndrome
Keywords: Diabetes mellitus.
Acute coronary syndrome.
Percutaneous coronary intervention.
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2012-09-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Number of patients who achieve inhibition of platelet aggregation greater that 50%
timeFrame: 24 to 36 hours post-PCI
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 30 days
measure: Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.
timeFrame: 30 days.
measure: Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy
timeFrame: 30 days.
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References:
citation: 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.