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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00250991
First received: November 7, 2005
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: activase
Drug: integrilin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage . [ Time Frame: within 36 hours ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: July 2003
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250991

Locations
United States, Arizona
Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd
Phoenix, Arizona, United States, 85013
United States, California
University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave.
Los Angeles, California, United States, 90024
St. John's Health Center, 1328 22nd St
Santa Monica, California, United States, 90404
Santa Monica-UCLA Medical Center, 1250 16th Street
Santa Monica, California, United States, 90404
United States, Kentucky
St. Elizabeth Medical Center South, One Medical Village Drive
Edgewood, Kentucky, United States, 41017
Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way
Louisville, Kentucky, United States, 40202
United States, Michigan
University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303
Ann Arbor, Michigan, United States, 48109-0303
United States, New York
Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue
New Hyde Park, New York, United States, 11040
United States, Ohio
Mercy Hospital, Mt Airy, 2446 Kipling Ave.
Cincinnati, Ohio, United States, 45239
The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd,
Cincinnati, Ohio, United States, 45236
Mercy Hospital, Western Hills, 3131 Queen City Ave.
Cincinnati, Ohio, United States, 45238
University of Cincinnati, University Hospital, 234 Goodman Ave.
Cincinnati, Ohio, United States, 45219
The Christ Hospital, 2139 Auburn Ave.
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital, 375 Dixmyth Ave.,
Cincinnati, Ohio, United States, 45220-2489
Bethesda North Hospital, 10500 Montgomery Rd
Montgomery, Ohio, United States, 45242
United States, Pennsylvania
Lehigh Valley Hospital, 1200 South Cedar Crest Blvd
Allentown, Pennsylvania, United States, 18103
University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University, Rhode Island Hospital, 593 Eddy St.
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University, University Hospital, 1211 22nd Ave. S.
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Arthur Pancioli, MD University of Cincinnati College of Medicine, Department of Emergency Medicine
  More Information

No publications provided

Responsible Party: Arthur Pancioli, MD, University of Cincinnati College of Medicine, Department of Emergency Medicine
ClinicalTrials.gov Identifier: NCT00250991     History of Changes
Other Study ID Numbers: P50NS044283
Study First Received: November 7, 2005
Last Updated: May 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
stroke
integrilin
eptifibatide
activase
recombinant tissue plasminogen activator
rt-PA
recombinant t-PA
SPOTRIAS

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Eptifibatide
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014