PharmacOdynamic compaRison of piTavastatin Versus atOrvastatin on Platelet Reactivity

NCT01648829 | Unknown Phase 4

• 1 other identifier: 449/2012/D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of platelet reaction units

  Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\])

  After 30 days of treatment with each drug

Secondary Outcomes (1)

• Frequency of high platelet reactivity

  After 30 days of treatment with each drug

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

os, 20 mg, once per day, for 30 days

Drug: Atorvastatin

Pitavastatin

ACTIVE COMPARATOR

os, 4 mg, once per day, for 30 days

Drug: Pitavastatin

Interventions

Atorvastatin DRUG

Patients will receive randomly atorvastatin (20 mg day) for 30 days

Also known as: Torvast, Pfizer, USA

Atorvastatin

Pitavastatin DRUG

Patients will receive randomly pitavastatin (4 mg day) for 30 days

Also known as: Livalo, Kowa Pharmaceuticals, Japan

Pitavastatin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University

Rome, 00166, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atorvastatin; pitavastatin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Francesco Pelliccia, MD

  Sapienza University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064997; f.pelliccia@mclink.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 24, 2012
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

IT (1)