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This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRX-801 | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic intracranial hemorrhage | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recanalization of occluded artery | 120 minutes | |
| Independent outcome (modified Rankin Scale 0-2) | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Molina Cateriano, MD | University Hospital Vall d'Hebron, Barcelona, Spain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35249 | United States | ||
| Barrow Neurology Clinics at St. Joseph's Hospital |
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| Phoenix |
| Arizona |
| 85013 |
| United States |
| Hoag Memorial Hospital | Newport Beach | California | 92658 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Christiana Care Health System | Newark | Delaware | 19718 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| St. Louis University School of Medicine | St Louis | Missouri | 63104 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Methodist Hospital Neurological Institute | Houston | Texas | 77030 | United States |
| University of Texas | Houston | Texas | 77030 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Bichat - Claude Bernard University Hospital and Medical School | Paris | France |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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