A Phase 2 interventional study of IV rt-PA in Acute Stroke, sponsored by Lee Schwamm. Completed at 14 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-06-15.
Sponsored by Lee Schwamm · Phase 2, Interventional, and Treatment
This study was jointly developed and is jointly led by investigators at Massachusetts General Hospital and the intramural division of NINDS. We are doing this research study to find out if Activase ® (also called alteplase or rt-PA) can safely be given to people with an acute ischemic stroke when their stroke onset was not witnessed making them ineligible for standard thrombolytic (clot busting) therapy. We also want to find out if rt-PA can help people recover better from their stroke.
The purpose of this study is to: 1) see if it is safe to give intravenous (IV) rt-PA to people with unwitnessed stroke but with MRI evidence of early ischemic stroke, 2) see if rt-PA is effective if given to people who are selected for treatment based on MRI evidence of an early stroke, and 3) get information about this new MRI diagnostic methods for guiding stroke treatment.
This study was jointly developed and is jointly led by Massachusetts General Hospital and the NINDS. This is a multi-center, open-label, Phase IIa safety study in adult acute ischemic stroke patients to determine if it is safe to extend intravenous thrombolytic treatment to subjects who are evaluated within 24 hours from last known well ("stroke onset") and eligible to receive thrombolytic treatment within 4.5 hours from symptom discovery with the assistance of an MRI-based "witness" when no human witness of stroke onset is available. The study is designed to investigate the safety in using standard diagnostic MRI in selecting patients for thrombolytic therapy when the last known well time places the patient beyond the current IV thrombolytic time-window.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 88 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Lee Schwamm as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
open-label
Drug: IV rt-PA
open-label
Also known as: Alteplase, Activase
Number of Subjects With Symptomatic Intracerebral Hemorrhage
Safety of IV rt-PA as evident by rates of symptomatic ICH defined by an increase of 4 points or more on the NIHSS .
Time frame: Within 7 days from tPA administration.
Number of Subjects With Symptomatic Cerebral Edema
Safety of IV rt-PA as evident by rates of symptomatic cerebral edema defined as brain edema with mass effect as the predominant cause of clinical deterioration.
Time frame: Within 96 hours of tPA administration
Subjects were recruited between January 2011 and February 2016 from 14 sites across the continental United States, and enrolled in 10 of those sites.
| Milestone | Primary SIR <1.15 | Secondary SIR <1.25 |
|---|---|---|
| Started | 80 | 8 |
| Completed | 80 | 8 |
| Not completed | 0 | 0 |
Safety of IV rt-PA as evident by rates of symptomatic ICH defined by an increase of 4 points or more on the NIHSS .
| Participants | SIR <1.15 | SIR < 1.25 |
|---|---|---|
| Number of Subjects With Symptomatic Intracerebral Hemorrhage | 1 | 1 |
Safety of IV rt-PA as evident by rates of symptomatic cerebral edema defined as brain edema with mass effect as the predominant cause of clinical deterioration.
| Participants | SIR <1.15 | SIR < 1.25 |
|---|---|---|
| Number of Subjects With Symptomatic Cerebral Edema | 3 | 0 |
Collected over Adverse events were collected from the time subjects were consented through study completion, a 90 day period, about 3 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SIR <1.15 | 7/80 (8.8%) | 22/80 (27.5%) | 56/80 (70%) |
| SIR <1.25 | 1/8 (12.5%) | 5/8 (62.5%) | 8/8 (100%) |
| Event | SIR <1.15 | SIR <1.25 |
|---|---|---|
| Cerebral HeamorrhageNervous system disorders | 2/80 | 1/8 |
| Cerebrovascular AccidentNervous system disorders | 3/80 | 1/8 |
| ANGIOEDEMAVascular disorders | 0/80 | 1/8 |
| BRAIN HERNIATIONNervous system disorders | 0/80 | 1/8 |
| CAROTID ARTERY STENOSISVascular disorders | 0/80 | 1/8 |
| FALLInjury, poisoning and procedural complications | 0/80 | 1/8 |
| MYOCARDIAL INFARCTIONVascular disorders | 0/80 | 1/8 |
| Brain OedemaNervous system disorders | 6/80 | 0/8 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 4/80 | 0/8 |
| Atrial FibrillationCardiac disorders | 3/80 | 0/8 |
| Event | SIR <1.15 | SIR <1.25 |
|---|---|---|
| PetechiaeSkin and subcutaneous tissue disorders | 4/80 | 2/8 |
| Heamorrhagic TransformationNervous system disorders | 18/80 | 1/8 |
| HeadacheNervous system disorders | 13/80 | 0/8 |
| Urinary Tract InfectionInfections and infestations | 12/80 | 0/8 |
| ConstipationGastrointestinal disorders | 7/80 | 1/8 |
| NauseaGastrointestinal disorders | 8/80 | 1/8 |
| AmnesiaNervous system disorders | 0/80 | 1/8 |
| ATELECTASISRespiratory, thoracic and mediastinal disorders | 0/80 | 1/8 |
| ATRIAL FIBRILLATIONVascular disorders | 0/80 | 1/8 |
| GINGIVAL BLEEDINGGeneral disorders | 0/80 | 1/8 |
Analysis population consists of all subjects enrolled who suffered an unwitnessed stroke and qualified per AHA guidelines to receive IV tPA within a window of 3-4.5 hours since symptom discovery and whose signal intensity ratio (SIR) on MRI was \<1.15 for primary arm and \<1.25 for secondary arm.
| Age, Continuous(years) | SIR <1.15 | SIR <1.25 | Total |
|---|---|---|---|
| Mean | 67.46 ± 13.5 | 67.13 ± 11.63 | 67.43 ± 13.26 |
| Sex: Female, Male(Participants) | SIR <1.15 | SIR <1.25 | Total |
|---|---|---|---|
| Female | 37 | 4 | 41 |
| Male | 43 | 4 | 47 |
| Ethnicity (NIH/OMB)(Participants) | SIR <1.15 | SIR <1.25 | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 0 | 6 |
| Not Hispanic or Latino | 73 | 8 | 81 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | SIR <1.15 | SIR <1.25 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 28 | 5 | 33 |
| White | 47 | 2 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| NIH Stroke Scale (NIHSS)(units on a scale) | SIR <1.15 | SIR <1.25 | Total |
|---|---|---|---|
| Mean | 9.31 ± 5.87 | 10.13 ± 4.64 | 9.35 ± 5.91 |
| Modified Rankin Scale(units on a scale) | SIR <1.15 | SIR <1.25 | Total |
|---|---|---|---|
| Mean | 0.48 ± 1.09 | 1.38 ± 2.26 | 1.18 ± 1.72 |
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