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The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verapamil 10 mg Treatment Group | Experimental | Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (10 mg) Verapamil. |
|
| Verapamil 20 mg Treatment Group | Experimental | Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (20 mg) Verapamil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mg Intra-arterial Verapamil | Drug | Intra-arterial delivery of verapamil following mechanical thrombectomy procedure will be administered at a randomized dose of 10 mg or 20 mg to consenting patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Bleeding Complications | Bleeding Complications including: symptomatic intracerebral hemorrhage (sICH), and Hemorrhagic Transformation (HT) | 3 months |
| Number of Participants with a Serious Adverse Event of Death | Death | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcomes | Change in modified Rankin Scale (mRS) Score | 30-days and 90-days |
| Functional Outcomes | Change in National Institutes of Health Stroke Scale (NIHSS) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AtlantiCare Regional Medical Center | Recruiting | Atlantic City | New Jersey | 08401 | United States |
IPD will not be shared as this is a pilot study.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Each trial participant is randomly assigned to one of two total intervention groups. The first intervention group will receive a dose of 10mg Verapamil, while the second intervention group will receive a dose of 20mg Verapamil. Both treatment groups will have Verapamil administered intra-arterially following mechanical thrombectomy.
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| 20 mg Intra-arterial Verapamil | Drug | Intra-arterial delivery of verapamil following mechanical thrombectomy procedure will be administered at a randomized dose of 10 mg or 20 mg to consenting patients. |
|
| 30-days and 90-days |
| Neuroimaging | MRI/ CT Scan | 180 Days, 365 Days |
| St Mary Medical Center | Not yet recruiting | Langhorne | Pennsylvania | 19047 | United States |
|
| Crozer Chester Medical Center | Completed | Upland | Pennsylvania | 19013 | United States |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |