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Completed

NCT Number: NCT01526460

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IRCCS San Raffaele Monte Tabor

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

atorvastatin

Drug

80 mg

Other names: TORVAST, TOTALIP

Rosuvastatin

Drug

40 mg

Other names: CRESTOR

Placebo

Drug

no statin loading dose

Other names: NO STATIN DRUGS

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study 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)

Acronym: STATIPLAT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2012
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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