Tenecteplase in Stroke Patients Between 4.5 and 24 Hours
Public ClinicalTrials.gov record NCT03785678. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Prospective, Double-blind, Randomized, Placebo-controlled Trial of Thrombolysis in Imaging-eligible, Late-window Patients to Assess the Efficacy and Safety of Tenecteplase (TIMELESS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS). All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all participants will undergo multimodal CT or MRI at baseline. Only participants with a vessel occlusion (ICA or MCA M1/M2) and penumbral tissue will be randomized. The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90.
Study identification
- NCT ID
- NCT03785678
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 458 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2, 2019 (Actual)
- Primary completion
- Feb 28, 2023 (Actual)
- Completion
- Feb 28, 2023 (Actual)
- Last update posted
- May 22, 2024
2019 – 2023
United States locations
- U.S. sites
- 94
- U.S. states
- 27
- U.S. cities
- 77
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | — |
| Banner Desert Medical Center | Mesa | Arizona | 85202 | — |
| Kaiser Permanente - Anaheim (E. La Palma) | Anaheim | California | 92806 | — |
| Mills-Peninsula Medical Center | Burlingame | California | 94010 | — |
| John Muir Health, Concord Medical Center | Concord | California | 94520 | — |
| Sutter Davis Hospital | Davis | California | 95616 | — |
| Kaiser Permanente - Fontana | Fontana | California | 92335 | — |
| Adventist Health Glendale | Glendale | California | 91206 | — |
| Kaiser Permanente South Bay Medical Center | Harbor City | California | 90710 | — |
| UCSD Medical Center - La Jolla | La Jolla | California | 92037 | — |
| Kaiser Permanente Los Angeles | Los Angeles | California | 90027 | — |
| University of Southern California Medical Center | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Cedars-Sinai Marina Del Rey Hospital | Marina del Rey | California | 90292 | — |
| Kaiser Permanente - Ontario | Ontario | California | 91761 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Sutter Roseville Medical Center | Roseville | California | 95661 | — |
| Sutter Medical Group, Neurology | Sacramento | California | 95816 | — |
| UCSD - Hillcrest; Hillcrest Medical Center | San Diego | California | 92103 | — |
| CPMC - Van Ness Campus | San Francisco | California | 94109 | — |
| CPMC - Davies Campus | San Francisco | California | 94114 | — |
| Torrance Memorial Medical Center | Torrance | California | 90505 | — |
| John Muir Medical Center-Walnut Creek | Walnut Creek | California | 94598 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| University of Florida Health at Shands | Gainesville | Florida | 32608 | — |
| Baptist Medical Center - Jacksonville | Jacksonville | Florida | 32207-8202 | — |
| Baptist Medical Center-South | Jacksonville | Florida | 32258 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| The Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | — |
| St. Catherine Hospital | East Chicago | Indiana | 46312 | — |
| St. Mary Medical Center | Hobart | Indiana | 46432 | — |
| Community Hospital | Munster | Indiana | 46321 | — |
| Uni of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Baptist Health Corbin | Corbin | Kentucky | 40701 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Univ of Michigan Medical Ctr | Ann Arbor | Michigan | 48109-0718 | — |
| Henry Ford Macomb Hospital - Clinton Township | Clinton Township | Michigan | 48038 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| McLaren Flint | Flint | Michigan | 48532 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| ProMedica Monroe Regional Hospital | Monroe | Michigan | 48162 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Fairview Southdale | Edina | Minnesota | 55435 | — |
| U of Minnesota MedCtr Fairview | Minneapolis | Minnesota | 55455 | — |
| Sanford Worthington Medical Center | Worthington | Minnesota | 56187 | — |
| Washington University | St Louis | Missouri | 63128 | — |
| JFK Neuroscience Institute | Edison | New Jersey | 08820 | — |
| Atlantic Health System - Overlook Medical Center | Summit | New Jersey | 07901 | — |
| Capital Health Regional Medical Center | Trenton | New Jersey | 08638 | — |
| Buffalo General Medical Center | Buffalo | New York | 14203 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Mission Hospitals Inc | Asheville | North Carolina | 28803 | — |
| Guilford Neurologic Research | Greensboro | North Carolina | 27405 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Riverside Methodist Hospital; Cancer Services | Columbus | Ohio | 43214-1419 | — |
| Grant Medical Center | Columbus | Ohio | 43215 | — |
| Doctors Hospital | Columbus | Ohio | 43228 | — |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | — |
| Ascension St. John | Tulsa | Oklahoma | 74104 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Adventist Health Portland | Portland | Oregon | 97216 | — |
| Providence Saint Vincent's Medical Center | Portland | Oregon | 97225 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| UPMC East Hospital | Monroeville | Pennsylvania | 15146 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Uni of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC Mercy | Pittsburgh | Pennsylvania | 15219 | — |
| UPMC Passavant Hospital | Pittsburgh | Pennsylvania | 15237 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Sanford Neurology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Chattanooga Center for Neurologic Research | Chattanooga | Tennessee | 37404 | — |
| Saint Thomas Rutherford Hospital | Murfreesboro | Tennessee | 37129 | — |
| Saint Thomas Health | Nashville | Tennessee | 37205 | — |
| Saint Thomas Midtown Hospital | Nashville | Tennessee | 37232 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| Dell Seton Medical center at the University of Texas | Austin | Texas | 78701 | — |
| Seton Medical Center Austin | Austin | Texas | 78705 | — |
| Valley Baptist Medical Center-Brownsville | Brownsville | Texas | 78520 | — |
| Baylor University Medical Center | Dallas | Texas | 75231 | — |
| Valley Baptist Medical Center | Harlingen | Texas | 78550 | — |
| University of Texas at Houston; Neurology | Houston | Texas | 77030 | — |
| Ascension Seton Hays | Kyle | Texas | 78640 | — |
| Ascension Seton Williamson | Round Rock | Texas | 78665 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| University of Virginia | Charlottesville | Virginia | 22906 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03785678, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03785678 live on ClinicalTrials.gov.