VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel (VERDI)
|ClinicalTrials.gov Identifier: NCT01684813|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : September 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type II Acute Coronary Syndrome||Drug: Prasugrel. Drug: Clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Active Comparator: Clopidogrel
This group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg.
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.
Other Name: Agrelan
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).
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.
Other Name: Efient, Eli Lilly
- Number of patients who achieve inhibition of platelet aggregation greater that 50% [ Time Frame: 24 to 36 hours post-PCI ]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.
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 30 days ]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. [ Time Frame: 30 days. ]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 [ Time Frame: 30 days. ]To analyze the characteristics of patients who are non-responsive to anti-aggregation therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684813
|Hospital Universitario Virgen del Rocío|
|Seville, Spain, 41013|