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

Acute Coronary Syndrome Clinical Trial

— VERDI  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684813
• Other study ID #: VERDI study
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2012
• Last updated: September 19, 2014
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Andaluz Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability	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).	30 days	Yes
Secondary	Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.	To assess the results in different sub-groups and analyze the combined endpoint of cardiovascular death, MI or recurrent ischemia at 30 days.	30 days.	Yes
Secondary	Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy	To analyze the characteristics of patients who are non-responsive to anti-aggregation therapy.	30 days.	No