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

NCT01684813 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-09-22

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Type II
  • Acute Coronary Syndrome

Interventions

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.

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.

Sponsors & Collaborators

  • Andaluz Health Service

    collaborator OTHER_GOV

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684813 on ClinicalTrials.gov