Coronary Artery DiseasePhase 4PEARLNCT01567774
Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on Platelet Reactivity
A Phase 4 study testing Atorvastatin and Rosuvastatin in people with Coronary Artery Disease, run by University of Roma La Sapienza at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Atorvastatin and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2012to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Francesco Pelliccia, MD contact
Italy2 sites, 2 recruiting
- Recruiting
Sapienza University
Rome, 00161
Francesco Pelliccia, MD, 064997 ext. 123, f.pelliccia@mclink.it
Francesco Pelliccia, MD
- Not yet recruiting
University Sapienza
Rome, 00166
Francesco Pelliccia, MD, +3906499 ext. 123, f.pelliccia@mclink.it
About this study
Official title: Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on pLatelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual Antiplatelet Therapy
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.
Read more
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.
Read the detailed description
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
- Coronary Artery Disease
- Being tested
- Atorvastatin, Rosuvastatin
- Keywords
- Coronary artery disease, dual antiplatelet therapy, atorvastatin, rosuvastatin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Norvasc, Pfizer, USA
os, 20 mg, once per day, for 30 days
RosuvastatinDrug
Also called Crestor, AstraZeneca, UK
os, 10 mg, once per day, for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Patients will receive randomly atorvastatin (20 mg day) for 30 days Receives: Drug: Atorvastatin |
| Rosuvastatin | Active comparator | Patients will receive randomly rosuvastatin (10 mg per day) for 30 days Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: After 30 days of treatment with each drug
Secondary outcomes (1)
Frequency of high platelet reactivity
Frequency of high platelet reactivity with the 2 study treatments (as defined by a Platelet Reaction Unit value>240
Measured: After 30 days of treatment with each drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Francesco Pelliccia, MD, Principal investigator, University Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567774
- Sponsor's protocol ID
- 198/2012/D
- Acronym
- PEARL
- Status last verified
- May 2013
- First submitted
- 29 Mar 2012
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24444439
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on pLatelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT01567774
- Acronym / sponsor ID
- PEARL / 198/2012/D
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, dual antiplatelet therapy, atorvastatin, rosuvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: AtorvastatinPatients will receive randomly atorvastatin (20 mg day) for 30 days |
| Rosuvastatin | Active comparator | Drug: RosuvastatinPatients will receive randomly rosuvastatin (10 mg per day) for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Norvasc, Pfizer, USAos, 20 mg, once per day, for 30 days | Drug | Atorvastatin |
| RosuvastatinAlso: Crestor, AstraZeneca, UKos, 10 mg, once per day, for 30 days | Drug | Rosuvastatin |
Primary outcome
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])
1 secondary outcome
Frequency of high platelet reactivity
Time frame: After 30 days of treatment with each drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
- Derived from this study: PubMed 24444439Pelliccia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Pelliccia, MD contact
Francesco Pelliccia, MD principal investigator
University Sapienza
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and Rosuvastatin in people with Coronary Artery Disease, run by University of Roma La Sapienza at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia, MD (+39064997 ext. 123, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of platelet reaction units (time frame: After 30 days of treatment with each drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01567774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.