A Phase 3 interventional study of Clopidogrel and prasugrel in Acute Coronary Syndrome, sponsored by Gennaro Sardella. Completed at 2 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-03-27.
Sponsored by Gennaro Sardella · Phase 3, Interventional, and Treatment
Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s. Interindividual variability in platelet response to clopidogrel has been reported, with several mechanisms being implicated for high post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated with an increased risk of adverse events after PCI. Studies in patients on chronic clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently present and independently predictive of adverse events. Optimization of platelet inhibition in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12 inhibitors is a controversial issue, mostly studied in post PCI patients, while no data exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours after the last study-drug dose, will follow by crossover directly to the alternate therapy for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will return for the clinical and laboratory assessment as did on Day 14 visit.
1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.
This study's enrollment of 30 is below the median of 200 across 880 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Gennaro Sardella is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Patients will be randomized to this arm to receive before high clopidogrel dose and after crossover they will receive standard dose of prasugrel
Drug: Clopidogrel · Drug: prasugrel
Patients will be randomized to this arm to receive before standard dose of prasugrel and after crossover they will receive high clopidogrel dose.
Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 14 days we will change their therapy with standard dose of prasugrel (crossover).
Patient will be randomized to this intervention will receive in the first time the standard dose of prasugrel and after 14 days we will change their therapy with high dose of clopidogrel (crossover).
antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR
The primary aim will be to investigate the antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR while receiving chronic clopidogrel treatment at the end of the 2 study periods (switching, crossover and post-crossover)
Time frame: 14-28 days
Bleeding (major, minor, or minimal according to the TIMI study criteria)
Bleeding (major, minor, or minimal according to the TIMI study criteria)
Time frame: 14-28 days
Major Adverse Cardiac Cerebrovascular Events
cardiovascular death, myocardial infarction, and stroke
Time frame: 14-28 days
The record gives a start of Oct 2011, a primary completion of Jan 2012 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Clopidogrel · Prasugrel
Gennaro Sardella