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Efficacy
Efficacy Introduction
Risk Reduction Pre-PCI
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Long-term Risk Reduction Post-PCI
Dosing Administration
Dosing Guidelines & Cockcroft-Gault Equation
Ease of Administration
Bolus Delivery
Infusion Delivery
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Safety
Major Bleeding in PCI
Minor Bleeding in PCI
Bleeding Rates in PROTECT
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PURSUIT
ESPRIT
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CLEAR PLATELETS
Clear Platelets Introduction
Platelet Aggregation Inhibition
Reduction of Troponin-I Release
Full Prescribing Information
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Clopidogrel Loading with Eptifibatide to Arrest the Reactivity of Platelets (CLEAR PLATELETS)1

Objective

To compare the antiplatelet effects of clopidogrel 300 mg or 600 mg alone and in combination with INTEGRILIN® in patients undergoing elective coronary artery stenting.

Design

Prospective, randomized trial of 120 patients undergoing elective coronary artery stenting.

INTEGRILIN® & Comparator Doses

Patients were assigned to 1 of 4 treatment regimens:
  • Group A—Clopidogrel 300 mg (n=30)
  • Group B—Clopidogrel 600 mg (n=30)
  • Group C—Clopidogrel 300 mg + INTEGRILIN® (n=30)*
  • Group D—Clopidogrel 600 mg + INTEGRILIN® (n=30)*

Results


  • The addition of INTEGRILIN® produced a >2-fold increase in platelet inhibition as compared with high-dose clopidogrel alone at 3, 8, and 18 to 24 hours after stenting
    (P=0.001).
  • INTEGRILIN® + clopidogrel consistently produced the lowest platelet reactivity over 24 hours: platelet response to 20 μmol/L ADP, P=0.001 for groups C and D vs groups A and B
  • Troponin-I release was significantly lower in groups receiving INTEGRILIN® + clopidogrel vs groups receiving clopidogrel alone (P=0.004)
  • CK-MB release (>1 to 3 times the upper limit of normal) was significantly lower in groups receiving INTEGRILIN® + clopidogrel (P=0.005)
* INTEGRILIN® 180-mcg/kg IV bolus, followed by a 2-mcg/kg/min infusion, with a second 180-mcg/kg bolus 10 minutes after the first bolus.
  The use of clopidogrel is not consistent with its FDA-approved Prescribing Information. Clinical relevance of this data has not been confirmed. The CLEAR PLATELETS study was not designed to provide definitive conclusions about the relation of platelet reactivity to clinical outcomes.
 

IMPORTANT PRESCRIBING AND SAFETY CONSIDERATIONS

Indications for INTEGRILIN® (eptifibatide) Injection:
  • For the treatment of patients with acute coronary syndrome (UA/NSTEMI), including patients who are
    to be managed medically and those undergoing percutaneous coronary intervention (PCI)
  • For the treatment of patients undergoing percutaneous coronary intervention (PCI), including those
    undergoing intracoronary stenting
Contraindicated in Patients With:
  • A history of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
  • Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately
    controlled on antihypertensive therapy
  • Major surgery within preceding 6 weeks
  • History of stroke within 30 days or any history of hemorrhagic stroke
  • Current or planned administration of another parenteral GP IIb-IIIa inhibitor
  • Dependency on renal dialysis
  • Known hypersensitivity to any component of the product
Precautions and Warnings:
  • In patients undergoing PCI, INTEGRILIN® (eptifibatide) Injection is associated with an increase in major and minor bleeding at the site of arterial sheath placement. Special care should be employed to minimize the risk of bleeding among these patients
  • If bleeding cannot be controlled with pressure, infusion of INTEGRILIN® and concomitant heparin should be stopped immediately
  • Because INTEGRILIN® inhibits platelet aggregation, caution should be employed when it is used with drugs that affect hemostasis, including thrombolytics, oral anticoagulants, NSAIDs, and dipyridamole
  • Use with other GP IIb-IIIa inhibitors should be avoided
  • INTEGRILIN® is cleared in part by the kidney and its plasma concentrations are doubled in patients with renal disease (creatinine clearance
    <50 mL/min). Therefore, the infusion dose of INTEGRILIN® needs to be reduced to 1 mcg/kg/min in these patients. INTEGRILIN® is contraindicated in patients who are dependent upon renal dialysis (please see dosing guidelines)
  • Caution should be exercised when administering eptifibatide to patients with a platelet count <100,000/mm3
  • Bleeding is the most common complication encountered during INTEGRILIN® therapy. The majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal, and retroperitoneal bleeding were seen more commonly with INTEGRILIN® compared with placebo.

For full Prescribing Information, click here. (PDF)(1.04MB)

About Schering-Plough
Schering Corporation, of Kenilworth, NJ, is a research-based company engaged in the discovery, development, manufacturing, and marketing of pharmaceutical products worldwide. For more information, please visit the company's Web site at www.sch-plough.com.

Contact us at 1-800-222-7579

Reference:

  • Gurbel PA, Bliden KP, Zaman KA, Yoho JA, Hayes KM, Tantry US. Clopidogrel loading with eptifibatide to arrest the reactivity of platelets: results of the Clopidogrel Loading With Eptifibatide to Arrest the Reactivity of Platelets (CLEAR PLATELETS) study. Circulation. 2005;111:1153–1159.

INTEGRILIN is a registered trademark of Millennium Pharmaceuticals, Inc.
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