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

NCT01977456 | Completed Phase 2 Results DMC

• 1 other identifier: P50NS044283-13
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

Brief 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 alone.

Conditions

Stroke; Brain Infarction

Keywords

acute ischemic stroke; stroke; rt-PA, thrombolytic; t-PA; recombinant tissue plasminogen activator; Activase; eptifibatide; Integrilin; fibrinolytic agents; clot dissolving; blood clot

Outcome Measures

Primary Outcomes (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

  within 36 hours after stroke onset

Secondary Outcomes (2)

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

  within 36 hours after stroke onset

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

  within 36 hours after stroke onset

Other Outcomes (1)

• The Number of Participants With Good Outcomes According to the Modified Rankin Score.

  90 days from the date of stroke onset

Study Arms (1)

Eptifibatide

EXPERIMENTAL

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

Interventions

Eptifibatide DRUG

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.

Also known as: Integrilin

Eptifibatide

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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).

Sponsors & Collaborators

• Arthur Pancioli: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (8)

St. Elizabeth Healthcare System Edgewood

Edgewood, Kentucky, 41017, United States

Location

St. Elizabeth Healthcare Florence

Florence, Kentucky, 41042, United States

Location

St. Elizabeth Healthcare Ft. Thomas

Fort Thomas, Kentucky, 41075, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Jewish Hospital

Cincinnati, Ohio, 45236, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Related Publications (1)

• 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.

  PMID: 26243231 RESULT

MeSH Terms

Conditions

Stroke; Brain Infarction; Ischemic Stroke; Thrombosis

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size and open design. Did not include endovascular therapy patients.

Results Point of Contact

• Title: Dr. Opeolu Adeoye
• Organization: University of Cincinnati

opeolu.adeoye@uc.edu

513-558-3117

Study Officials

• Opeolu Adeoye, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: sub investigator

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 6, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 21, 2016
• Results First Posted: November 25, 2015

Record last verified: 2015-10

Locations

US (8)