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

NCT ID: NCT01684813

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-10-31

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.

Conditions

Diabetes Mellitus Type II; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopidogrel

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

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Prasugrel.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Efient, Eli Lilly; Agrelan

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andaluz Health Service

OTHER_GOV

Sponsor Role: collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Virgen del Rocío

Seville, Seville, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 26717223 (View on PubMed)

Other Identifiers

VERDI study

Identifier Type: -

Identifier Source: org_study_id