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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Diabetes Mellitus Type II

Treatments

Drug: Prasugrel.

Drug: Clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT01684813

VERDI study

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
Previous inclusion of the patient in another study.
Treatment in research (medication or device) in the last 30 days prior.
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.