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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
activase
integrilin
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, integrilin, eptifibatide, activase, recombinant tissue plasminogen activator, rt-PA, recombinant t-PA, SPOTRIAS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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 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.

Sites / Locations

  • Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd
  • University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave.
  • Santa Monica-UCLA Medical Center, 1250 16th Street
  • St. John's Health Center, 1328 22nd St
  • St. Elizabeth Medical Center South, One Medical Village Drive
  • Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way
  • University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303
  • Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue
  • The Christ Hospital, 2139 Auburn Ave.
  • University of Cincinnati, University Hospital, 234 Goodman Ave.
  • Good Samaritan Hospital, 375 Dixmyth Ave.,
  • The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd,
  • Mercy Hospital, Western Hills, 3131 Queen City Ave.
  • Mercy Hospital, Mt Airy, 2446 Kipling Ave.
  • Bethesda North Hospital, 10500 Montgomery Rd
  • Lehigh Valley Hospital, 1200 South Cedar Crest Blvd
  • University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street
  • Brown University, Rhode Island Hospital, 593 Eddy St.
  • Vanderbilt University, University Hospital, 1211 22nd Ave. S.

Outcomes

Primary Outcome Measures

The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage .
The primary measure of early beneficial drug activity will be the incidence of early neurological improvement, as measured by the NIHSSS </= 2

Secondary Outcome Measures

Full Information

First Posted
November 7, 2005
Last Updated
May 7, 2009
Sponsor
University of Cincinnati
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00250991
Brief Title
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial
Official Title
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cincinnati
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)--to dissolve blood clots in patients who have a stroke.
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). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care and train acute stroke translational researchers. Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can affect a person's ability to walk, talk, and function independently. In order to reduce the risk of permanent damage, it is important to restore blood flow to the brain as quickly as possible. The CLEAR Stroke study will enroll 100 participants with acute stroke due to a blood clot. The purpose of this multi-center, randomized, double-blind study is to determine the effects of using a combination of two drugs, integrilin (or eptifibatide) and activase (or recombinant tissue plasminogen activator, rt-PA, recombinant t-PA), to dissolve blood clots. More specifically, the CLEAR study is being done to determine if a lower dose of activase, given in combination with a second drug, integrilin, is a safe treatment for acute stroke. Activase, used alone, is already approved by the Food and Drug Administration (FDA) as treatment for patients with a stroke caused by blockage of an artery in the brain and when given within 3 hours of the onset of stroke symptoms. Integrilin is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of integrilin for a stroke victim in combination with activase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, integrilin, eptifibatide, activase, recombinant tissue plasminogen activator, rt-PA, recombinant t-PA, SPOTRIAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
Double
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
activase
Intervention Type
Drug
Intervention Name(s)
integrilin
Primary Outcome Measure Information:
Title
The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage .
Time Frame
within 36 hours
Title
The primary measure of early beneficial drug activity will be the incidence of early neurological improvement, as measured by the NIHSSS </= 2
Time Frame
at 24 hours from symptom onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Pancioli, MD
Organizational Affiliation
University of Cincinnati College of Medicine, Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Santa Monica-UCLA Medical Center, 1250 16th Street
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
St. John's Health Center, 1328 22nd St
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
St. Elizabeth Medical Center South, One Medical Village Drive
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0303
Country
United States
Facility Name
Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
The Christ Hospital, 2139 Auburn Ave.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati, University Hospital, 234 Goodman Ave.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Good Samaritan Hospital, 375 Dixmyth Ave.,
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2489
Country
United States
Facility Name
The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd,
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Mercy Hospital, Western Hills, 3131 Queen City Ave.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45238
Country
United States
Facility Name
Mercy Hospital, Mt Airy, 2446 Kipling Ave.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45239
Country
United States
Facility Name
Bethesda North Hospital, 10500 Montgomery Rd
City
Montgomery
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Lehigh Valley Hospital, 1200 South Cedar Crest Blvd
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Brown University, Rhode Island Hospital, 593 Eddy St.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Vanderbilt University, University Hospital, 1211 22nd Ave. S.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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