Status:
COMPLETED
Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Platelet Dysfunction
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independen...
Detailed Description
An initial assessment of platelet reactivity in response to the TRAP (thrombin receptor agonist), ADP and arachidonic acid (respectively, indicative of the response to clopidogrel and aspirin) will be...
Eligibility Criteria
Inclusion
- Age: 18-75 years
- Patients with chronic stable angina
- Patients with coronary artery disease or with de novo stent restenosis of native vessels.
- Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent.
Exclusion
- Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI).
- Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel.
- Altered basal level of transaminase or CPK.
- Patient with history of hepatitis-acute/chronic.
- Patients already receiving high-dose statins.
- Contraindications to antiplatelet therapy.
- Patients with acute inflammatory disease and/or underlying chronic (hepatitis, pneumonia, urinary tract, rectum ulcerative colitis etc.).
- Patients with anemia (haemoglobin \<8.5 mg/dl), leukocytosis (WBC\> 12.000 mm3), leukopenia (WBC \<3000 mm3), platelet count \<100.000; hypersplenism.
- Patients with malignant disease.
- Patients enrolled in other studies not yet completed.
- Patients with known allergy / intolerance to statins.
- Pregnant women and women who are breastfeeding.
- Patients with myopathy (muscle pain and unexplained repeated)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01526460
Start Date
August 1 2011
End Date
February 1 2014
Last Update
March 6 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS San Raffaele Monte Tabor
Milan, Italy, 20132