A Phase 2 interventional study of Atorvastatin and Rosuvastatin in Platelet Dysfunction, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-03-06.
Sponsored by IRCCS San Raffaele · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.
An initial assessment of platelet reactivity in response to the TRAP (thrombin receptor agonist), ADP and arachidonic acid (respectively, indicative of the response to clopidogrel and aspirin) will be performed with impedance aggregometry (Multiplate® analyzer system). Patients with a increased residual platelet reactivity to ADP test (AUC > 47) will receive a different antiplatelet therapy and will then be excluded from the study, the other will be randomized to 3 groups of treatment.
IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Atorvastatin 80 mg
Drug: Atorvastatin
Rosuvastatin 40 mg
Drug: Rosuvastatin
No statin loading dose
Drug: Placebo
80 mg
Also known as: TORVAST, TOTALIP
40 mg
Also known as: CRESTOR
no statin loading dose
Also known as: NO STATIN DRUGS
Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer
Evaluation of the effect of a loading dose (LD) of two different statins on platelet reactivity (atorvastatin and rosuvastatin) in terms of difference between AUC value before statin LD and after 12 hrs statin LD. The Area Under the Aggregation Curve (AUC) will be measured with the Multiplate 5.0 system.
Time frame: Evaluation of platelet reactivity (in terms of AUC) two time points.
Incidence of periprocedural myocardial infarction
To evaluate if the loading dose of statin prevent the periprocedural myocardial damage measured by CK and CK-MB The measurments will be done once before the procedure and at 6 and 12 hours after.
Time frame: CK and CK-MB evaluated before the procedure and two time points up to 12 hours
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele