NCT01526460

Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Platelet Dysfunction

Interventions

Type	Name	Description
DRUG	Atorvastatin	80 mg
DRUG	Rosuvastatin	40 mg
DRUG	Placebo	no statin loading dose

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-02-03
• Last updated: 2014-03-06

Locations

1 site across 1 country: Italy