[c09aa8]: / clusters / clusters342final / clust_199.txt

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The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:* Cardiovascular disorders including:** Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening** Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment** Any history of congenital long QT syndrome** Any of the following within 6 months before the first dose of study treatment:*** Unstable angina pectoris*** Clinically-significant cardiac arrhythmias*** Stroke (including transient ischemic attack [TIA], or other ischemic event)*** Myocardial infarction*** Thromboembolic event requiring therapeutic anticoagulation (note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study)
Atherosclerotic cardiovascular disease (ASCVD) defined by history of acute coronary syndromes, myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin
Patients with a history of any of the following within the last 6 months prior to study entry are ineligible:* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)* Placement of a pacemaker for control of rhythm* New York Heart Association (NYHA) class III or IV heart failure* Pulmonary embolism
History of any of the following within the last 6 months prior to study entry:* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)* Placement of a pacemaker for control of rhythm* Pulmonary embolism
Ischemic myocardial event including angina requiring therapy and artery revascularization procedures
Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures
History of stroke or intracranial hemorrhage within 6 months prior to enrollment
History within 6 months prior to treatment of myocardial infarction, severe/unstable angina pectoris, coronary artery bypass graft (CABG), New York Heart Association (NYHA) class III or IV congestive heart failure (CHF), stroke or transient ischemic attack (TIA)
History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (cerebrovascular accident [CVA], stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment
Participants with a recent history (< 6 months) of a major infarct including but not inclusive to bowel ischemia, cerebral vascular accident, transient ischemic attack, myocardial infarction, limb ischemia, or skin necrosis
History of any of the following within the last 6 months prior to study entry:* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures * Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia) * Pulmonary embolism* New York Heart Association (NYHA) class III or IV heart failure * Placement of a pacemaker for control of rhythm
History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, hospitalization for acutely decompensated congestive heart failure
History of stroke or transient ischemic attack within six months
History of stroke or transient ischemic attack within six months
History of stroke or transient ischemic attack within 6 months prior to registration
Patients must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration; baseline echocardiogram within 28 days of registration must demonstrate an ejection fraction (EF) >= 50%; patients must have corrected QT (QTc) interval < 500 msec on prestudy electrocardiogram (EKG) and no known history of congenital long QT syndrome; patients must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 3 months prior to registration and not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 6 months of registration; prestudy EKG must be obtained within 28 days prior to registration
History of stroke or intracranial hemorrhage within 6 months prior to enrollment
No history of any prior stroke (hemorrhagic or ischemic)
History of stroke or transient ischemic attack within 6 months of the randomization
Patients with a history of the following within =< 6 months of study entry are NOT eligible:* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)* New York Heart Association (NYHA) class III or IV heart failure* Pulmonary embolism