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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Platelet Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorvastatin

Atorvastatin 80 mg

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

80 mg

Rosuvastatin

Rosuvastatin 40 mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

40 mg

No statin loading dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

no statin loading dose

Interventions

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Atorvastatin

80 mg

Intervention Type DRUG

Rosuvastatin

40 mg

Intervention Type DRUG

Placebo

no statin loading dose

Intervention Type DRUG

Other Intervention Names

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TORVAST TOTALIP CRESTOR NO STATIN DRUGS

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No