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StrokePhase 2CLEAR-FDRNCT01977456

Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)

A Phase 2 study testing Eptifibatide in people with Stroke and Brain Infarction, run by Arthur Pancioli at 8 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 primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke, Brain Infarction
What is being tested?
Eptifibatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
8 sitesUnited States
Study dates
Sep 2013to Apr 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 85 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 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.

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 27Show 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 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Jewish Hospital

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • St. Elizabeth Healthcare System Edgewood

    Edgewood, Kentucky, 41017

  • St. Elizabeth Healthcare Florence

    Florence, Kentucky, 41042

  • St. Elizabeth Healthcare Ft. Thomas

    Fort Thomas, Kentucky, 41075

Other trials in United States

About this study

Official title: Phase 2 The Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Full Dose Regimen(CLEAR-FDR)

The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.

Read the detailed description

The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Full Dose Regimen (CLEAR-FDR Stroke Trial) is a Phase II trial and 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.

rt-PA, 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. Eptifibatide is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of eptifibatide for a stroke victim in combination with rt-PA.

The CLEAR Stroke Trial demonstrated that the combination of low dose rt-PA plus eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.

The CLEAR-ER Stroke Trial demonstrated that the combination of medium dose rt-PA plus eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.

The CLEAR-FDR Stroke Trial is designed to provide data concerning the risks when combining eptifibatide with full dose intravenous rt-PA in 30 acute ischemic stroke patients within 3 hours of symptom onset.

Being tested
Eptifibatide
Keywords
acute ischemic stroke, stroke, rt-PA, thrombolytic, t-PA, recombinant tissue plasminogen activator, Activase, eptifibatide, Integrilin, fibrinolytic agents, clot dissolving, blood clot
Medical subject headings
Stroke, Brain Infarction, Ischemic Stroke, Thrombosis

What participants receive

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

  • EptifibatideDrug

    Also called Integrilin

    IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.

Study groups in NCT01977456
Study groupRoleWhat they receive
EptifibatideExperimentalAll subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Receives: Drug: Eptifibatide

What is being measured

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

  1. The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH).

    Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator

    Measured: within 36 hours after stroke onset

Secondary outcomes (2)

  1. The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH).

    Any ICH symptomatic (as defined above) or asymptomatic (that visualized on CT or MRI only)

    Measured: within 36 hours after stroke onset

  2. The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2).

    Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT

    Measured: within 36 hours after stroke onset

Timeline

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

  1. First posted6 Nov 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJan 2015
  4. Study completionApr 2015

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01977456
Sponsor's protocol ID
P50NS044283-13
Other IDs
P50NS044283-13
Acronym
CLEAR-FDR
Status last verified
Oct 2015
First submitted
18 Oct 2013
Last updated
21 Jan 2016
Data monitoring committee
Yes

Publications

  • Adeoye O, Sucharew H, Khoury J, Vagal A, Schmit PA, Ewing I, Levine SR, Demel S, Eckerle B, Katz B, Kleindorfer D, Stettler B, Woo D, Khatri P, Broderick JP, Pancioli AM. Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue-Type Plasminogen Activator in Acute Ischemic Stroke-Full Dose Regimen Stroke Trial. Stroke. 2015 Sep;46(9):2529-33. doi: 10.1161/STROKEAHA.115.010260. Epub 2015 Aug 4.

    PubMed 26243231

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eptifibatide in people with Stroke and Brain Infarction, run by Arthur Pancioli at 8 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 27 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 25 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH). (time frame: within 36 hours after stroke onset). 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 NCT01977456, which also lists 1 linked publication.

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 21 Jan 2016.

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