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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Cincinnati
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arthur Pancioli, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01977456
First received: October 18, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Brain Infarction
Drug: Eptifibatide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 The Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Full Dose Regimen(CLEAR-FDR)

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • The number of patients who experience symptomatic intracerebral hemorrhage (sICH). [ Time Frame: 36 hours after stroke onset ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of patients who experience any intracerebral hemorrhage (ICH). [ Time Frame: 36 hours after stroke onset ] [ Designated as safety issue: Yes ]
  • The number of patients who develop parenchymal hemorrhage types 1( PH-1) and 2 (PH-2). [ Time Frame: 36 hours after stroke onset ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Other outcomes include the modified Rankin score. [ Time Frame: 90 days from the date of stroke onset ] [ Designated as safety issue: No ]
    dichotomized to 0-1 or return to baseline


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eptifibatide
All 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.
Drug: Eptifibatide
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.
Other Name: Integrilin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 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 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.

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 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.
  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: NCT01977456

Contacts
Contact: Pamela A Schmit, RN BSN 513-558-6142 pamela.schmit@uc.edu
Contact: Opeolu Adeoye, MD MS 513-515-3853 opeolu.adeoye@uc.edu

Locations
United States, Kentucky
St. Elizabeth Healthcare System Edgewood Recruiting
Edgewood, Kentucky, United States, 41017
Principal Investigator: Opeolu Adeoye, MD MS         
St. Elizabeth Healthcare Florence Recruiting
Florence, Kentucky, United States, 41042
Principal Investigator: Opeolu Adeoye, MD MS         
St. Elizabeth Healthcare Ft. Thomas Recruiting
Ft. Thomas, Kentucky, United States, 41075
Principal Investigator: Opeolu Adeoye, MD MS         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Opeolu Adeoye, MD MS         
Jewish Hospital Recruiting
Cincinnati, Ohio, United States, 45236
Principal Investigator: Opeolu Adeoye, MD MS         
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Opeolu Adeoye, MD MS         
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Principal Investigator: Opeolu Adeoye, MD MS         
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Principal Investigator: Opeolu Adeoye, MD MS         
Sponsors and Collaborators
Arthur Pancioli
Investigators
Principal Investigator: Opeolu Adeoye, MD University of Cincinnati
  More Information

Additional Information:
No publications provided

Responsible Party: Arthur Pancioli, sub investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01977456     History of Changes
Other Study ID Numbers: P50NS044283-13, P50NS044283-13
Study First Received: October 18, 2013
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
acute ischemic stroke
stroke
rt-PA, thrombolytic
t-PA
recombinant tissue plasminogen activator
Activase
eptifibatide
Integrilin
fibrinolytic agents
clot dissolving
blood clot

Additional relevant MeSH terms:
Infarction
Stroke
Cerebral Infarction
Brain Infarction
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Fibrinolytic Agents
Tissue Plasminogen Activator
Eptifibatide
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014