Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention (STATIPLAT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI)|
- Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer [ Time Frame: Evaluation of platelet reactivity (in terms of AUC) two time points. ] [ Designated as safety issue: No ]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.
- Incidence of periprocedural myocardial infarction [ Time Frame: CK and CK-MB evaluated before the procedure and two time points up to 12 hours ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Atorvastatin
Atorvastatin 80 mg
Active Comparator: Rosuvastatin
Rosuvastatin 40 mg
Other Name: CRESTOR
Placebo Comparator: No statin loading dose
No statin loading dose
no statin loading dose
Other Name: NO STATIN DRUGS
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.
|Contact: Antonio Colombo, MD||+39022643 ext email@example.com|
|Contact: Cosmo Godino, MD||+39022643 ext firstname.lastname@example.org|
|IRCCS San Raffaele Monte Tabor||Recruiting|
|Milan, Italy, 20132|
|Contact: Antonio Colombo, MD +39022643 ext 7331 email@example.com|
|Contact: Cosmo Godino, MD +39022643 ext 3752 firstname.lastname@example.org|
|Principal Investigator: Antonio Colombo, MD|
|Sub-Investigator: Cosmo Godino, MD|
|Sub-Investigator: Alaide Chieffo, MD|
|Principal Investigator:||Antonio Colombo, MD||IRCCS San Raffaele Monte Tabor|