Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors (Trial gRANADa) (gRANADa)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Atorvastatin
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Angiographically-proven coronary artery disease;
- Able to understand and willing to sign the informed CF;
- Stable clinical condition;
- treatment with dual antiplatelet therapy (with P2Y12 inhibitors);
Exclusion Criteria:
- Other drugs or medications that affect CYP mediated drug metabolism;
- Allergy or adverse reactions to administered drugs;
Sites / Locations
- Sapienza Univeristy of Rome
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
atorvastatin
rosuvastatin
Arm Description
Patients were randomly assigned to atorvastatin (40 mg day) or rosuvastatin (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
Patients were randomly assigned to atorvastatin (40 mg day) or rosuvastatin(20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
Outcomes
Primary Outcome Measures
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]
Secondary Outcome Measures
Frequency of high platelet reactivity
Frequency of high platelet reactivity with the 2 study treatments (as defined by a Platelet Reaction Unit value>208
Full Information
NCT ID
NCT02030054
First Posted
January 6, 2014
Last Updated
December 3, 2014
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02030054
Brief Title
Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors (Trial gRANADa)
Acronym
gRANADa
Official Title
Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Statin interference has been suggested among the mechanisms of reduction of the antiplatelet effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery disease undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a single-center, prospective, randomized, crossover study conducted in the Department of Heart and Great Vessels "Attilio Reale", Sapienza University, Rome, Italy. All consecutive patients undergone PTCA in our institution in the period between July 2013 and December 2013 will be eligible to be enrolled.
Patients will be offered to participate to the trial at time of 1-month post-angioplasty follow-up visit.patients receiving dual antiplatelet therapy (prasugrel 10 mg or brilique 90 mg x 2 plus aspirin 100 mg) after percutaneous coronary intervention. Patients were randomly assigned to rosuvastatin (20 mg day) or atorvastatin (40 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
Platelet function will be evaluated using a validated method: the VerifyNow System (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system that measures platelet-induced aggregation. Platelet function will be measured with the VerifyNow P2Y12 test at baseline and after 30 days from rosuvastatin or atorvastatin administration.
Platelet reactivity will be expressed in P2Y12 reaction units (PRU). PRU values >208 are suggestive of high platelet reactivity.
Detailed Description
Statin interference has been suggested among the mechanisms of reduction of the antiplatelet effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery disease undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a single-center, prospective, randomized, crossover study conducted in the Department of Heart and Great Vessels "Attilio Reale", Sapienza University, Rome, Italy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
atorvastatin
Arm Type
Active Comparator
Arm Description
Patients were randomly assigned to atorvastatin (40 mg day) or rosuvastatin (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
Arm Title
rosuvastatin
Arm Type
Active Comparator
Arm Description
Patients were randomly assigned to atorvastatin (40 mg day) or rosuvastatin(20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
torvast, totalip
Intervention Description
Patients were randomly assigned to atorvastatin (40 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
crestor, provisacor,
Intervention Description
Patients were randomly assigned to rosuvastatin (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
Primary Outcome Measure Information:
Title
Assessment of platelet reaction units
Description
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]
Time Frame
After 30 days of treatment with each drug
Secondary Outcome Measure Information:
Title
Frequency of high platelet reactivity
Description
Frequency of high platelet reactivity with the 2 study treatments (as defined by a Platelet Reaction Unit value>208
Time Frame
After 30 days of treatment with each drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Angiographically-proven coronary artery disease;
Able to understand and willing to sign the informed CF;
Stable clinical condition;
treatment with dual antiplatelet therapy (with P2Y12 inhibitors);
Exclusion Criteria:
Other drugs or medications that affect CYP mediated drug metabolism;
Allergy or adverse reactions to administered drugs;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MD MARINA POLACCO, medicine
Phone
+393333347960
Email
dott.mpolacco@gmail.com
Facility Information:
Facility Name
Sapienza Univeristy of Rome
City
Rome
ZIP/Postal Code
00166
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MD MARINA POLACCO, medicine
Phone
+393333347960
Email
dott.mpolacco@gmail.com
First Name & Middle Initial & Last Name & Degree
MD Marina Polacco, medicine
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors (Trial gRANADa)
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