NCT01567774

Brief Summary

Patients with coronary artery disease (CAD) are often treated with dual antiplatelet therapy (DAT), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events. Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel. Atorvastatin and simvastatin are metabolized by CYP3A4 \[Clin pharmacokinetic 2002; 41: 343-70\], whereas the cytochrome P450 mediated metabolism of rosuvastatin appears to be minimal and principally mediated by the 2C9 isoenzyme, with little involvement of CYP3A4 \[Clin Ther 2003; 25: 2822-5.\]. Previous studies comparing atorvastatin versus rosuvastatin by means of ex vivo platelet function tests have yielded conflicting results.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2012

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

March 29, 2012

Last Update Submit

May 3, 2013

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseasedual antiplatelet therapyatorvastatinrosuvastatin

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

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

Drug: Atorvastatin

Rosuvastatin

ACTIVE COMPARATOR

Patients will receive randomly rosuvastatin (10 mg per day) for 30 days

Drug: Rosuvastatin

Interventions

AtorvastatinDRUG

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

Also known as: Norvasc, Pfizer, USA
Atorvastatin
RosuvastatinDRUG

os, 10 mg, once per day, for 30 days

Also known as: Crestor, AstraZeneca, UK
Rosuvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sapienza University

Rome, 00161, Italy

RECRUITING

University Sapienza

Rome, 00166, Italy

NOT YET RECRUITING

Related Publications (1)

  • Pelliccia F, Rosano G, Marazzi G, Vitale C, Spoletini I, Franzoni F, Speziale G, Polacco M, Greco C, Gaudio C. Pharmacodynamic effects of atorvastatin versus rosuvastatin in coronary artery disease patients with normal platelet reactivity while on dual antiplatelet therapy--the PEARL randomized cross-over study. Eur J Pharmacol. 2014 Feb 15;725:18-22. doi: 10.1016/j.ejphar.2014.01.006. Epub 2014 Jan 17.

    PMID: 24444439DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

AtorvastatinAmlodipineRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDihydropyridinesPyridinesSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Francesco Pelliccia, MD

    University Sapienza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064997f.pelliccia@mclink.it

Francesco Pelliccia, MD

CONTACT

+39064997

Study Design

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

Study Record Dates

First Submitted

March 29, 2012

First Posted

March 30, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

June 1, 2015

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

IT(2)