Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention (STATIPLAT)

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. Identifier: NCT01526460
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : March 6, 2014
Information provided by (Responsible Party):
Antonio Colombo, IRCCS San Raffaele

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 independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.

Condition or disease Intervention/treatment Phase
Platelet Dysfunction Drug: Atorvastatin Drug: Rosuvastatin Drug: Placebo Phase 2

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 performed with impedance aggregometry (Multiplate® analyzer system). Patients with a increased residual platelet reactivity to ADP test (AUC > 47) will receive a different antiplatelet therapy and will then be excluded from the study, the other will be randomized to 3 groups of treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI)
Study Start Date : August 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Active Comparator: Atorvastatin
Atorvastatin 80 mg
Drug: Atorvastatin
80 mg
Other Names:

Active Comparator: Rosuvastatin
Rosuvastatin 40 mg
Drug: Rosuvastatin
40 mg
Other Name: CRESTOR

Placebo Comparator: No statin loading dose
No statin loading dose
Drug: Placebo
no statin loading dose

Primary Outcome Measures :
  1. Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer [ Time Frame: Evaluation of platelet reactivity (in terms of AUC) two time points. ]
    Evaluation of the effect of a loading dose (LD) of two different statins on platelet reactivity (atorvastatin and rosuvastatin) in terms of difference between AUC value before statin LD and after 12 hrs statin LD. The Area Under the Aggregation Curve (AUC) will be measured with the Multiplate 5.0 system.

Secondary Outcome Measures :
  1. Incidence of periprocedural myocardial infarction [ Time Frame: CK and CK-MB evaluated before the procedure and two time points up to 12 hours ]
    To evaluate if the loading dose of statin prevent the periprocedural myocardial damage measured by CK and CK-MB The measurments will be done once before the procedure and at 6 and 12 hours after.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526460

IRCCS San Raffaele Monte Tabor
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Principal Investigator: Antonio Colombo, MD IRCCS San Raffaele Monte Tabor

Responsible Party: Antonio Colombo, MD, IRCCS San Raffaele Identifier: NCT01526460     History of Changes
Other Study ID Numbers: STATIPLAT
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014

Keywords provided by Antonio Colombo, IRCCS San Raffaele:

Additional relevant MeSH terms:
Atorvastatin Calcium
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors