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Clinical Trial Details

Trial ID: L4446
Source ID: NCT01684813
Associated Drug: Prasugrel.
Title: VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel
Acronym: VERDI
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type II|Acute Coronary Syndrome
Interventions: DRUG: Prasugrel.|DRUG: Clopidogrel
Outcome Measures: 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 | 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|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.|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.
Sponsor/Collaborators: Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Collaborators: Andaluz Health Service
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 65
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-10
Completion Date: 2013-10
Results First Posted:
Last Update Posted: 2014-09-22
Locations: Hospital Universitario Virgen del Rocío, Seville, 41013, Spain
URL: https://clinicaltrials.gov/show/NCT01684813