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StrokePhase 1/2NCT00250991

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

A Phase 1/2 study testing activase and integrilin in people with Stroke, run by University of Cincinnati at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
activase and integrilin
How many people
94 participants
Where
19 sitesUnited States
Study dates
Jul 2003to Jul 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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.
  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Lehigh Valley Hospital, 1200 South Cedar Crest Blvd

    Allentown, Pennsylvania, 18103

  • University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303

    Ann Arbor, Michigan, 48109-0303

  • The Christ Hospital, 2139 Auburn Ave.

    Cincinnati, Ohio, 45219

  • University of Cincinnati, University Hospital, 234 Goodman Ave.

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital, 375 Dixmyth Ave.,

    Cincinnati, Ohio, 45220-2489

  • The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd,

    Cincinnati, Ohio, 45236

  • Mercy Hospital, Western Hills, 3131 Queen City Ave.

    Cincinnati, Ohio, 45238

  • Mercy Hospital, Mt Airy, 2446 Kipling Ave.

    Cincinnati, Ohio, 45239

  • St. Elizabeth Medical Center South, One Medical Village Drive

    Edgewood, Kentucky, 41017

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

    Los Angeles, California, 90024

  • Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way

    Louisville, Kentucky, 40202

  • Bethesda North Hospital, 10500 Montgomery Rd

    Montgomery, Ohio, 45242

  • Vanderbilt University, University Hospital, 1211 22nd Ave. S.

    Nashville, Tennessee, 37232

  • Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue

    New Hyde Park, New York, 11040

  • University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street

    Philadelphia, Pennsylvania, 19104

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

    Phoenix, Arizona, 85013

  • Brown University, Rhode Island Hospital, 593 Eddy St.

    Providence, Rhode Island, 02903

  • Santa Monica-UCLA Medical Center, 1250 16th Street

    Santa Monica, California, 90404

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

    Santa Monica, California, 90404

Other trials in United States

About this study

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.

Read the 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.

Conditions
Stroke
Being tested
activase, integrilin
Keywords
stroke, integrilin, eptifibatide, activase, recombinant tissue plasminogen activator, rt-PA, recombinant t-PA, SPOTRIAS
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • activaseDrug

  • integrilinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage .

    Measured: within 36 hours

  2. The primary measure of early beneficial drug activity will be the incidence of early neurological improvement, as measured by the NIHSSS </= 2

    Measured: at 24 hours from symptom onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2005 (estimated)
  2. Study startJul 2003
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00250991
Sponsor's protocol ID
P50NS044283
Status last verified
May 2009
First submitted
7 Nov 2005
Last updated
8 May 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing activase and integrilin in people with Stroke, run by University of Cincinnati at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage . (time frame: within 36 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00250991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2009.

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