Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke
CLEAR-ER
The "Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Enhanced Regimen" (CLEAR-ER Stroke Trial)
2 other identifiers
interventional
126
1 country
20
Brief Summary
The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 7, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
March 17, 2014
CompletedApril 17, 2014
March 1, 2014
3.3 years
May 6, 2009
November 27, 2013
March 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset
Primary safety outcome measure - 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
Within 36 hours of initiation of therapy
Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline
Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of '6', and assigned the "bad" outcome. Also those lost to follow-up were assigned the "bad" outcome. The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care).
90 days from treatment onset
Secondary Outcomes (2)
Barthel Index ≥ 95
90 days from treatment onset
Glasgow Outcome Scale (GOS) of 1
90 days from treatment onset
Other Outcomes (8)
Serious Systemic Bleeding
Within 7 days of treatment onset
Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset
Within 7 days of treatment onset
Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset
Within 7 days of treatment onset
- +5 more other outcomes
Study Arms (2)
rt-PA only
ACTIVE COMPARATORSubject will receive the standard dose (0.9mg/kg) of IV rt-PA given over 60 minutes. One out of 6 subjects will be in this group.
rt-PA and Eptifibatide
EXPERIMENTALSubject will receive the standard dose (0.9mg/kg) of IV rt-PA. This IV dose will be discontinued at 40 minutes. The subject will immediately receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Five out of six subjects will be in this group.
Interventions
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.
Intravenous recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 Iinternational Normalized Ratio (INR) \> 1.7.
- Baseline lab values: positive urine pregnancy test, glucose \< 50 or \> 400 mg/dl, platelets \<100,000 /mm3, Hct (hematocrit) \<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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90024, United States
University of California San Diego
San Diego, California, 92103, United States
UCLA Medical Center Santa Monica
Santa Monica, California, 90404, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
St. Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017, United States
St. Elizabeth Healthcare Florence
Florence, Kentucky, 41042, United States
St. Elizabeth Healthcare Ft. Thomas
Fort Thomas, Kentucky, 41075, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Mission Hospital, Inc.
Asheville, North Carolina, 28801, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University Hospital
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220-2489, United States
The Jewish Hospital
Cincinnati, Ohio, 45236, United States
Mercy Hospital, Western Hills
Cincinnati, Ohio, 45238, United States
Mercy Hospital Mt Airy
Cincinnati, Ohio, 45239, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Related Publications (2)
Barreto AD, Pedroza C, Grotta JC. Adjunctive medical therapies for acute stroke thrombolysis: is there a CLEAR-ER choice? Stroke. 2013 Sep;44(9):2377-9. doi: 10.1161/STROKEAHA.113.001830. Epub 2013 Jul 25. No abstract available.
PMID: 23887845BACKGROUNDPancioli AM, Adeoye O, Schmit PA, Khoury J, Levine SR, Tomsick TA, Sucharew H, Brooks CE, Crocco TJ, Gutmann L, Hemmen TM, Kasner SE, Kleindorfer D, Knight WA, Martini S, McKinney JS, Meurer WJ, Meyer BC, Schneider A, Scott PA, Starkman S, Warach S, Broderick JP; CLEAR-ER Investigators. Combined approach to lysis utilizing eptifibatide and recombinant tissue plasminogen activator in acute ischemic stroke-enhanced regimen stroke trial. Stroke. 2013 Sep;44(9):2381-7. doi: 10.1161/STROKEAHA.113.001059. Epub 2013 Jul 25.
PMID: 23887841RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Arthur Pancioli
- Organization
- University of Cincinnati
Study Officials
- PRINCIPAL INVESTIGATOR
Arthur M Pancioli, MD
University of Cincinnati College of Medicine Department of Emergency Medicine
- PRINCIPAL INVESTIGATOR
Opeolu M Adeoye, MD
University of Cincinnati College of Medicine Department of Emergency Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dir Academic Med
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 7, 2009
Study Start
July 1, 2009
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
April 17, 2014
Results First Posted
March 17, 2014
Record last verified: 2014-03