Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial

Lead Sponsor:

University of Cincinnati

Collaborating Sponsors:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Stroke

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

PHASE2

Brief Summary

The purpose of this study is determine the effects of using of a combination of two drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)...

Detailed Description

The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) trial is part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). T...

Eligibility Criteria

Inclusion

  • 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 that intravenous study drug is begun.
  • Age: 18 through 80 years (i.e. candidates must have had their 18th birthday, but not had their 81st birthday).
  • Intravenous therapy must be initiated within 3 hours of onset of stroke symptoms.

Exclusion

  • 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 prothrombin time greater than 15 or INR \> 1.4
  • 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
  • If heparin has been administered within 48 hours, the patient must have a normal partial thromboplastin time (PTT)
  • 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.
  • Exclusion Criteria/CT Scan:
  • 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.

Key Trial Info

Start Date :

July 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT00250991

Start Date

July 1 2003

End Date

July 1 2007

Last Update

May 8 2009

Active Locations (19)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (19 locations)

1

Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd

Phoenix, Arizona, United States, 85013

2

University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave.

Los Angeles, California, United States, 90024

3

Santa Monica-UCLA Medical Center, 1250 16th Street

Santa Monica, California, United States, 90404

4

St. John's Health Center, 1328 22nd St

Santa Monica, California, United States, 90404