Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on Platelet Reactivity (PEARL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01567774|
Recruitment Status : Unknown
Verified May 2013 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was: Recruiting
First Posted : March 30, 2012
Last Update Posted : May 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Atorvastatin Drug: Rosuvastatin||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on pLatelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual Antiplatelet Therapy|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||June 2015|
Active Comparator: Atorvastatin
Patients will receive randomly atorvastatin (20 mg day) for 30 days
os, 20 mg, once per day, for 30 days
Other Name: Norvasc, Pfizer, USA
Active Comparator: Rosuvastatin
Patients will receive randomly rosuvastatin (10 mg per day) for 30 days
os, 10 mg, once per day, for 30 days
Other Name: Crestor, AstraZeneca, UK
- Assessment of platelet reaction units [ Time Frame: After 30 days of treatment with each drug ]Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California])
- Frequency of high platelet reactivity [ Time Frame: After 30 days of treatment with each drug ]Frequency of high platelet reactivity with the 2 study treatments (as defined by a Platelet Reaction Unit value>240
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567774
|Contact: Francesco Pelliccia, MD||+39064997 ext firstname.lastname@example.org|
|Contact: Francesco Pelliccia, MD||+39064997 ext 123|
|Rome, Italy, 00161|
|Contact: Francesco Pelliccia, MD 064997 ext 123 email@example.com|
|Principal Investigator: Francesco Pelliccia, MD|
|University Sapienza||Not yet recruiting|
|Rome, Italy, 00166|
|Contact: Francesco Pelliccia, MD +3906499 ext 123 firstname.lastname@example.org|
|Principal Investigator:||Francesco Pelliccia, MD||University Sapienza|