Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01977456
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a serious measurable neurological deficit on the NIH Stroke Scale due to focal brain ischemia.
* An NIH Stroke Scale score \>5 at the time the rt-PA is begun.
* Age: 18 through 85 years (i.e. candidates must have had their 18th birthday, but not had their 86th birthday).
* Intravenous rt-PA therapy must be initiated within 3 hours of onset of stroke symptoms.
Exclusion Criteria:
* History of stroke in the past 3 months.
* Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
* Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal.
* Hypertension at time of treatment; systolic BP \> 185 or diastolic \> 110 mmHg or aggressive measures to lower blood pressure to below these limits are needed.
* Presumed septic embolus.
* Presumed pericarditis including pericarditis after acute myocardial infarction.
* Recent (within 30 days) surgery or biopsy of parenchymal organ.
* Recent (within 30 days) trauma, with internal injuries or ulcerative wounds.
* Recent (within 90 days) severe head trauma or head trauma with loss of consciousness.
* Any active or recent (within 30 days) serious systemic hemorrhage.
* Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with International Normalized Ratio (INR) \> 1.7.
* Baseline lab values: positive urine pregnancy test, glucose \< 50 or \> 400 mg/dl, platelets \<100,000 /mm3, Hct \<25 %, or creatinine \> 4 mg/dl.
* Ongoing renal dialysis, regardless of creatinine.
* Subjects who received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) as deep vein thrombosis (DVT) prophylaxis or in full dose within the previous 24 hours.
* Subjects who received heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, or lepirudin) within 48 hours from screening must have had a normal partial prothrombin time (PTT).
* Subjects who received Factor Xa inhibitors (such as fondaparinux) or direct thrombin inhibitors (such as dabigatran) within the last 4 days.
* Arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days.
* Seizure at onset of stroke.
* Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
* Other serious, advanced, or terminal illness or any other condition that the investigator feels would pose a significant hazard to the patient if rt-PA or eptifibatide therapy were initiated.
* Patients whose peripheral venous access is so poor that they are unable to have two standard peripheral intravenous lines started.
* Current participation in another research drug treatment protocol. Patient cannot start another experimental agent until after 90 days.
* Informed consent is not or cannot be obtained.
* Any known history of amyloid angiopathy.
* High density lesion consistent with hemorrhage of any degree.
* Significant mass effect with midline shift.
* Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01977456
Study Brief:
Protocol Section:
NCT01977456