Multi-arm Optimization of Stroke Thrombolysis (MOST): a Single Blinded, Randomized Controlled Adaptive, Multi-arm, Adjunctive-thrombolysis Efficacy Trial in Ischemic Stroke

Who is this study for? Adult patients with Acute Ischemic Stroke
Status: Completed
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with standard of care thrombolysis (0.9mg/kg IV rt-PA or 0.25mg/kg IV tenecteplase or TNK) within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Acute ischemic stroke patients

• Treated with 0.9mg/kg IV rt-PA or 0.25mg/kg IV TNK within 3 hours of stroke onset or time last known well

• Age ≥ 18

• NIHSS score ≥ 6 prior to IV thrombolysis

• Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV thrombolysis

Locations
United States
Alabama
University of Alabama Hospital
Birmingham
California
St. Jude Medical Center
Fullerton
UCSD Health La Jolla
La Jolla
Cedars-Sinai Medical Center
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
UC Irvine Medical Center
Orange
UCSD Medical Center - Hillcrest Hospital
San Diego
San Francisco General Hospital
San Francisco
UCSF Medical Center
San Francisco
Santa Barbara Cottage Hospital
Santa Barbara
Connecticut
Yale New Haven Hospital
New Haven
Florida
Baptist Medical Center Jacksonville
Jacksonville
Mayo Clinic Hospital
Jacksonville
Jackson Memorial Hospital
Miami
Sarasota Memorial Hospital
Sarasota
Tampa General Hospital
Tampa
Georgia
Grady Memorial Hospital
Atlanta
Illinois
University of Chicago Medical Center
Chicago
Loyola University Medical Center
Maywood
Javon Bea Hospital - Riverside
Rockford
Central DuPage Hospital
Winfield
Kansas
University of Kansas Hospital
Kansas City
Kentucky
University of Kentucky Hospital
Lexington
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts General Hospital
Boston
UMASS Memorial Medical Center
Worcester
Michigan
University of Michigan University Hospital
Ann Arbor
Henry Ford Hospital
Detroit
McLaren Flint
Flint
Trinity Health Saint Mary's
Grand Rapids
Minnesota
Fairview Southdale Hospital
Edina
University of Minnesota Medical Center Hospital
Minneapolis
Regions Hospital
Saint Paul
Missouri
Saint Luke's Hospital
Kansas City
Barnes Jewish Hospital
St Louis
St. Louis University Hospital
St Louis
North Carolina
Forsyth Medical Center
Winston-salem
Wake Forest Baptist Medical Center
Winston-salem
New Mexico
University of New Mexico Hospital
Albuquerque
New York
North Shore University Hospital
Manhasset
Mount Sinai Beth Israel
New York
SUNY Upstate University Hospital
Syracuse
Ohio
Cleveland Clinic Akron General
Akron
Mercy Health West Hospital
Cincinnati
The Jewish Hospital
Cincinnati
University of Cincinnati Medical Center
Cincinnati
OSU Wexner Medical Center
Columbus
Oklahoma
St. John Medical Center
Tulsa
Pennsylvania
Abington Memorial Hospital
Abington
Hospital of the University of Pennsylvania
Philadelphia
Temple University Hospital
Philadelphia
UPMC Mercy Hospital
Pittsburgh
UPMC Presbyterian Hospital
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Prisma Health Greenville Memorial Hospital
Greenville
Tennessee
Vanderbilt University Hospital
Nashville
Texas
Houston Methodist Hospital
Houston
Memorial Hermann-Texas Medical Center
Houston
South Texas Health System McAllen
Mcallen
Utah
University of Utah Healthcare
Salt Lake City
Virginia
UVA Medical Center
Charlottesville
Time Frame
Start Date: 2019-10-15
Completion Date: 2024-10-31
Participants
Target number of participants: 514
Treatments
Experimental: Argatroban
100µg/kg bolus followed by 3µg/kg per minute for 12 hours
Experimental: Eptifibatide
135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov