Tenecteplase in Stroke Patients Between 4.5 and 24 Hours

PHASE3CompletedINTERVENTIONAL
Enrollment

458

Participants

Timeline

Start Date

March 2, 2019

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

Conditions
THROMBOLYSIS
Interventions
BIOLOGICAL

Tenecteplase

The investigational medicinal product (IMP) for this study is tenecteplase. The recommended total dose for this study is weight-based with 0.25 mg of tenecteplase per kg, not exceeding a maximum dose of 25 mg. A single bolus dose should be administered over 5 seconds based on patient weight.

OTHER

Placebo

Placebo is being used as the comparator since a thrombolytic is only FDA-approved in the United States for use out to 3 hours, and the standard of care guidelines support use out to 4.5 hours.

Trial Locations (97)

10032

Columbia University Medical Center, New York

14203

Buffalo General Medical Center, Buffalo

15146

UPMC East Hospital, Monroeville

15213

University of Pittsburgh Medical Center, Pittsburgh

15219

UPMC Mercy, Pittsburgh

15237

UPMC Passavant Hospital, Pittsburgh

19104

Penn Presbyterian Medical Center, Philadelphia

Uni of Pennsylvania, Philadelphia

19107

Pennsylvania Hospital, Philadelphia

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins, Baltimore

22906

University of Virginia, Charlottesville

27405

Guilford Neurologic Research, Greensboro

28803

Mission Hospitals Inc, Asheville

32258

Baptist Medical Center-South, Jacksonville

32608

University of Florida Health at Shands, Gainesville

33136

Jackson Memorial Hospital, Miami

37129

Saint Thomas Rutherford Hospital, Murfreesboro

37205

Saint Thomas Health, Nashville

37232

Saint Thomas Midtown Hospital, Nashville

Vanderbilt University, Nashville

37404

Chattanooga Center for Neurologic Research, Chattanooga

40503

Baptist Health Lexington, Lexington

40701

Baptist Health Corbin, Corbin

43215

Grant Medical Center, Columbus

43228

Doctors Hospital, Columbus

43606

ProMedica Toledo Hospital, Toledo

44195

Cleveland Clinic, Cleveland

45219

Univ of Cincinnati, Cincinnati

46312

St. Catherine Hospital, East Chicago

46321

Community Hospital, Munster

46432

St. Mary Medical Center, Hobart

48038

Henry Ford Macomb Hospital - Clinton Township, Clinton Township

48162

ProMedica Monroe Regional Hospital, Monroe

48202

Henry Ford Hospital, Detroit

48532

McLaren Flint, Flint

49503

Spectrum Health Hospitals, Grand Rapids

55337

Fairview Ridges Hospital, Burnsville

55435

Fairview Southdale, Edina

55455

U of Minnesota MedCtr Fairview, Minneapolis

56187

Sanford Worthington Medical Center, Worthington

57104

Sanford Neurology Clinic, Sioux Falls

60068

Advocate Lutheran General Hospital, Park Ridge

60453

Advocate Christ Medical Center, Oak Lawn

60611

Northwestern University, Chicago

63128

Washington University, St Louis

66160

Uni of Kansas Medical Center, Kansas City

74104

Ascension St. John, Tulsa

75231

Baylor University Medical Center, Dallas

77030

University of Texas at Houston; Neurology, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

78520

Valley Baptist Medical Center-Brownsville, Brownsville

78550

Valley Baptist Medical Center, Harlingen

78640

Ascension Seton Hays, Kyle

78665

Ascension Seton Williamson, Round Rock

78701

Dell Seton Medical center at the University of Texas, Austin

78705

Seton Medical Center Austin, Austin

85202

Banner Desert Medical Center, Mesa

90027

Kaiser Permanente Los Angeles, Los Angeles

90033

University of Southern California Medical Center, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90292

Cedars-Sinai Marina Del Rey Hospital, Marina del Rey

90505

Torrance Memorial Medical Center, Torrance

90710

Kaiser Permanente South Bay Medical Center, Harbor City

91206

Adventist Health Glendale, Glendale

91761

Kaiser Permanente - Ontario, Ontario

92037

UCSD Medical Center - La Jolla, La Jolla

92103

UCSD - Hillcrest; Hillcrest Medical Center, San Diego

92335

Kaiser Permanente - Fontana, Fontana

92806

Kaiser Permanente - Anaheim (E. La Palma), Anaheim

94010

Mills-Peninsula Medical Center, Burlingame

94109

CPMC - Van Ness Campus, San Francisco

94114

CPMC - Davies Campus, San Francisco

94304

Stanford University Medical Center, Palo Alto

94520

John Muir Health, Concord Medical Center, Concord

94598

John Muir Medical Center-Walnut Creek, Walnut Creek

95616

Sutter Davis Hospital, Davis

95661

Sutter Roseville Medical Center, Roseville

95816

Sutter Medical Group, Neurology, Sacramento

96813

The Queen's Medical Center, Honolulu

97213

Providence Portland Medical Center, Portland

97216

Adventist Health Portland, Portland

97225

Providence Saint Vincent's Medical Center, Portland

97239

Oregon Health and Science University, Portland

35294-3300

University of Alabama at Birmingham, Birmingham

06102

Hartford Hospital, Hartford

32207-8202

Baptist Medical Center - Jacksonville, Jacksonville

02114

Massachusetts General Hospital, Boston

48109-0718

Univ of Michigan Medical Ctr, Ann Arbor

08820

JFK Neuroscience Institute, Edison

07901

Atlantic Health System - Overlook Medical Center, Summit

08638

Capital Health Regional Medical Center, Trenton

43214-1419

Riverside Methodist Hospital; Cancer Services, Columbus

02903

Rhode Island Hospital, Providence

T6G 2G3

Uni of Alberta, Edmonton

L8L 2X2

Hamilton General Hospital; Pharmacy, Hamilton

H3A 2B4

Montreal Neurological Inst; Clinical Research Unit, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY