Trial to Assess the Safety and Effects of SCH 530348 in Japanese Subjects With Acute Coronary Syndrome (P04772)(COMPLETED)

Inclusion Criteria:

• Men and women aged 18 years or more with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at least 1 of the following A or B. Subjects who are planned to undergo PCI will be the target subjects.

  • A: Positive biomarkers [Elevated troponin I or CK-MB greater than the site's upper limit of normal (ULN)] at or before registration
  • B: Electrocardiogram (ECG) changes: ST segment depression >= 0.1 mV (>=1 mm), or transient (<30 minutes) ST segment elevation >= 0.1 mV (>=1 mm) in at least 2 contiguous leads
• Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.
• Women of child-bearing potential (all postmenarchal women who are <1 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication.

Exclusion Criteria:

• Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
• Any serious illness or any condition that the investigator feels would pose a significant hazard to the subject if investigational therapy were initiated
• known hypersensitivity to any component of the current investigational product;
• Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment
• Member of the staff personnel directly involved with this study;
• Family member of the investigational study staff;
• History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
• History of a hemorrhagic stroke at any time
• Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy;
• Major surgery within 2 weeks prior to enrollment
• Known platelet count <100,000/mm^3
• Uncontrolled cardiac arrhythmia;
• Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease;
• Active or chronic hepatobiliary or hepatic disease, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) activity more than two times greater than the upper limit of the laboratory reference range
• Anticipated staged PCI
• Concurrent or anticipated treatment with warfarin, factor Xa inhibitor, direct thrombin inhibitor, or antiplatelet agents except aspirin and ticlopidine after enrollment
• Anticipated intracoronary brachytherapy