Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST)

INCLUSION CRITERIA

• Diagnosis of acute ischemic stroke with planned start of intravenous tPA. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be at baseline.
• Disabling neurological deficit attributable to acute ischemic stroke.
• NIHSS less than or equal to 21 for left hemisphere strokes, NIHSS less than or equal to 16 for others.
• Age 18-85 years, inclusive.
• Body weight greater than 50 kg.

For MRI Arm only:

• Screening MRI diagnostic of focal cerebral ischemia corresponding to the clinical deficits. The MRI evaluation must involve echo planar diffusion weighted imaging, magnetic resonance angiography(MRA),and MRI perfusion. A normal appearing MRA with an appropriate perfusion deficit is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal appearing diffusion weighted image (DWI) are eligible.
• Evidence on perfusion weighted image (PWI) MRI or a perfusion defect corresponding to the acute stroke syndrome. The PWI will be assessed by relative mean transit time (MTT) images obtained prior to the start of tPA therapy.

EXCLUSION CRITERIA

• Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial.
• Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
• Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia; 2) EKG findings of ST elevation of more greater than 0.2 millivolts (mV) in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3) Elevated troponin I.
• Acute Pericarditis.
• Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
• Patients who would refuse blood transfusions if medically indicated.
• Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2).
• High clinical suspicion of septic embolus.
• Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
• Baseline NIHSS greater than 21 for left hemisphere stroke or greater than 16 for others.
• Evidence of acute or chronic ICH by head CT or MRI.
• CT or MRI evidence of non-vascular cause for the neurological symptoms.
• Signs of mass effect causing shift of midline structures on CT or MRI.
• Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control.
• Anticipated need for major surgery within 72 hours after start of study drugs, such as a carotid endarterectomy or hip fracture repair.
• Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months.
• Stroke within the past 3 months.
• History of ICH at any time in the past.
• Major trauma at the time of stroke, such as a hip fracture.
• Blood glucose greater than 200 milligrams per diluent (mg/dl).
• Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation.
• Intracranial aneurysm, unless surgically or endovascularly treated more than 3 months before.
• Seizure at the onset of stroke.
• Active internal bleeding.