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

Primary Purpose

Diabetes Mellitus Type II, Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Prasugrel.

Clopidogrel

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type II focused on measuring Diabetes mellitus., Acute coronary syndrome., Percutaneous coronary intervention.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clopidogrel

Prasugrel

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT01684813

First Posted

September 11, 2012

Last Updated

September 19, 2014

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Andaluz Health Service

1. Study Identification

Unique Protocol Identification Number

NCT01684813

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Andaluz Health Service

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type II, Acute Coronary Syndrome

Keywords

Diabetes mellitus., Acute coronary syndrome., Percutaneous coronary intervention.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel

Arm Type

Active Comparator

Arm Description

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

Arm Title

Prasugrel

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Prasugrel.

Other Intervention Name(s)

Efient, Eli Lilly

Intervention Description

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

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Agrelan

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of patients who achieve inhibition of platelet aggregation greater that 50%

Description

Time Frame

24 to 36 hours post-PCI

Secondary Outcome Measure Information:

Title

Number of participants with adverse events as a measure of safety and tolerability

Description

Time Frame

30 days

Title

Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.

Description

To assess the results in different sub-groups and analyze the combined endpoint of cardiovascular death, MI or recurrent ischemia at 30 days.

Time Frame

30 days.

Title

Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy

Description

To analyze the characteristics of patients who are non-responsive to anti-aggregation therapy.

Time Frame

30 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Hospital Universitario Virgen del Rocío

City

Seville

ZIP/Postal Code

41013

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

26717223

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.

Results Reference

derived

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

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