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. Author manuscript; available in PMC: 2014 Mar 31.
Published in final edited form as: Stroke. 2013 Jul 25;44(9):2381–2387. doi: 10.1161/STROKEAHA.113.001059

Table 1.

Inclusion and Exclusion Criteria

Inclusion criteria
 1. Patients must have had a serious measurable neurological deficit on the NIH Stroke Scale caused by focal brain ischemia
 2. An NIH Stroke Scale score >5 at the time the rt-PA was begun
 3. Age: 18 to 85 y (ie, candidates must have had their 18th birthday, but not had their 86th birthday)
 4. Intravenous rt-PA therapy must have been initiated within 3 h of onset of stroke symptoms
Exclusion criteria
 Clinical
  1. History of stroke in the past 3 mo
  2. Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
  3. Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal
  4. Hypertension at time of treatment; systolic BP >185 or diastolic >110 mm Hg, or aggressive measures to lower blood pressure to below these limits were needed
  5. Presumed septic embolus
  6. Presumed pericarditis, including pericarditis after acute myocardial infarction
  7. Recent (within 30 d) surgery or biopsy of parenchymal organ
  8. Recent (within 30 d) trauma, with internal injuries or ulcerative wounds
  9. Recent (within 90 d) severe head trauma or head trauma with loss of consciousness
  10. Any active or recent (within 30 d) serious systemic hemorrhage
  11. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >1.7
  12. Baseline laboratory values: positive urine pregnancy test, glucose <50 or >400 mg/dL, platelets <100 000/mm3, Hct <25%, or creatinine >4 mg/dL
  13. Ongoing renal dialysis, regardless of creatinine
  14. If heparin was administered within 48 h from screening, the patient must have had a normal partial thromboplastin time (PTT)
  15. Subjects who received low molecular weight heparins (such as dalteparin, enoxaparin, and tinzaparin) as DVT prophylaxis or in full dose within the previous 24 h
  16. Subjects who received heparin or a direct thrombin inhibitor (such as bivalirudin, argrtroban, or lepirudin) within 48 h from screening must have had a
    normal PTT
  17. Subjects took Factor Xa inhibitors (such as fondaparinux) within the last 4 d
  18. Subjects who received glycoprotein IIb/IIIa inhibitors within the past 2 wk
  19. Arterial puncture at a noncompressible site or a lumbar puncture in the previous 7 d
  20. Seizure at onset of stroke
  21. Preexisting neurological or psychiatric disease which confounded the neurological or functional evaluations
  22. Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if rt-PA or
    eptifibatide therapy was initiated
  23. Patients whose peripheral venous access was so poor that they were unable to have 2 standard peripheral intravenous lines started
  24. Current participation in another research drug treatment protocol. Subjects could not start another experimental agent until after 90 d
  25. Informed consent was not or could not be obtained
  26. Any known history of amyloid angiopathy
 CT scan exclusions
  1. High-density lesion consistent with hemorrhage of any degree
  2. Significant mass effect with midline shift
  3. Large (more than one third of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. Sulcal effacement and loss of gray-white
   differentiation alone were not contraindications for treatment

BP indicates blood pressure; CT, computed tomography; DVT, deep venous thrombosis; INR, international normalized ratio; NIH, National institutes of Health; and rt-PA, recombinant tissue plasminogen activator.