PharmacOdynamic compaRison of piTavastatin Versus atOrvastatin on Platelet Reactivity

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Levels of platelet reactivity in patients on Dual Antiplatelet Therapy (DAPT) can be influenced by concomitant treatment with medications (i.e. statins) that inhibit the CYP3A4 system involved in the activation of clopidogrel. Atorvastatin and simvastatin are metabolized by CYP3A4. Pitavastatin, unlike other statins, is little metabolized, most of the dose being excreted unchanged in bile, and biotransformation through the cytochrome P450 system is minimal. Indeed, pitavastatin's cyclopropyl group diverts the drug away from metabolism by CYP3A4 and allows only a small amount of clinically insignificant metabolism by CYP2C9.

The primary objective of this study is to compare the pharmacodynamic effects of a CYP3A4-metabolized statin (atorvastatin) versus a non-CYP3A4-metabolized statin (pitavastatin) in patients showing high platelet reactivity while on DAPT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Atorvastatin; Atorvastatin Calcium; Pitavastatin

Criteria

Inclusion Criteria:

• Angiographically-proven coronary artery disease

• Class I indication to DAT because of recent (< 12 months) percutaneous coronary intervention and/or recent acute coronary syndrome (< 12 months)

• Stable clinical conditions

• Able to understand and willing to sign the informed CF

Exclusion Criteria:

• Use of other drug interfering with CYP activity such as proton pump inhibitors

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT