Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on Platelet Reactivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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At least 1 month after starting DAT (clopidogrel 75 mg and aspirin 100 mg), patients will receive randomly atorvastatin (20 mg day, N=50) or rosuvastatin (10 mg bid, N=50) for 30 days (until T-1).

At this time-point, there will be a wash-out period of 15 days after the first treatment with atorvastatin or rosuvastatin in order to avoid any carry-over effect.

Afterwards, a cross-over will be performed, and patients will be switched to the other drug which will be continued for further 30 days (until T-2).

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atorvastatin

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

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Rosuvastatin

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

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

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

Interventions

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Atorvastatin

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

Intervention Type DRUG

Rosuvastatin

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

Intervention Type DRUG

Other Intervention Names

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Norvasc, Pfizer, USA Crestor, AstraZeneca, UK

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No