A Phase 1 interventional study of Verapamil in Ischemic Stroke, sponsored by Justin Fraser. Completed at 1 site in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-01-23.
Sponsored by Justin Fraser · Phase 1, Interventional, and Treatment
The purpose of this study is to determine whether super-selective intra-arterial administration of verapamil immediately following successful intra-arterial thrombolysis is safe as a potential neuroprotective agent. Standard procedures are cerebral angiography and intra-arterial thrombolysis (intra-arterial administration of tPA and/or mechanical thrombectomy). Experimental procedure is superselective injection of verapamil intra-arterially.
This trial represents the first time that verapamil will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombolysis. The methods for administration, along with the routinized followup, will provide a paradigm for studying other potential neuroprotective agents. Subjects will undergo cerebral angiography with intra-arterial thrombolysis, which is standard of care. 'Intra-arterial thrombolysis will include possible intra-arterial administration of tPA, as well as possible mechanical thrombectomy with an accepted thrombectomy device. This includes the Mercí Retriever (Concentric Medical, Mountain View, CA), the Penumbra System (Penumbra, Alameda, CA), the Solitaire stent-triever (EV3, Covidien, Irvine, CA), and the Trevo stent-triever (Concentric Medical, Mountain View, CA). Immediately after the intra-arterial thrombolysis component of the angiographic procedure is completed, the microcatheter used during the procedure will be left in or guided into the vessel location of the clot. 10mg of verapamil in 20cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot. At the conclusion of infusion, the microcatheter will be removed. Angiography through the guide catheter of the cerebral circulation in question will be performed to ensure no new thromboembolic event from the microcatheterization (standard of care). The catheters will be removed, and the arterial puncture site closed in the standard fashion. Patients will receive a noncontrast CT scan or MRI approximately 24 hours after intervention to determine the presence or absence of intracerebral hemorrhage (ICH) after intervention. This would be considered standard practice for intra-arterial thrombolysis. Both imaging studies can detect ICH, and the choice of one or the other will be determined by clinical criteria; CT or MRI may be preferable for different reasons depending upon the patient's clinical scenario. The determination of hemorrhage will be made by the official dictation of a diagnostic neuroradiologist not directly involved in the study. The hemorrhage will be considered an adverse event if it is deemed symptomatic in accordance with the criteria used in the International Management of Stroke (IMS) III study. Briefly, a hemorrhage is defined as symptomatic if occurring within 24+/-6 hours after study inclusion, temporally related to the intervention, and occurs with worsening neurological status as documented in the clinical exam. A 4 point or more increase in the NIHSS stroke scale would qualify as a significant worsening in status. Furthermore, hemorrhage that requires intervention surgically or endovascularly would be deemed significant.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 11 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Justin Fraser is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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For reference, the TICI Scale is defined below:
0 = No Perfusion
2B = Perfusion of 50% or greater (but not complete) of the vascular distribution of the occluded artery 3 = Full perfusion with filling of all distal branches
Exclusion Criteria:
Super-selective intra-arterial administration of 10 mg verapamil immediately following successful intra-arterial thrombolysis
Drug: Verapamil
Super-selective intra-arterial administration of 10mg verapamil in 20cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot, immediately following successful intra-arterial thrombolysis. Half-life is 2.8-7.4 hrs.
Also known as: Isoptin, Verelan, Verelan PM, Calan, Bosoptin, Calaptin, Covera-HS
The primary endpoint will be the presence or absence of intracranial hemorrhage
Patients will receive a noncontrast CT scan or MRI approximately 24 hours after intervention to determine the presence or absence of intracerebral hemorrhage (ICH) after intervention.
Time frame: 24-48 hours after treatment
Absence of intracranial hemorrhage
Improved clinical outcomes at followup intervals as measured by the modified Rankin score.
Time frame: At follow-up intervals: Day 30 ± 14 days, 3 Months ± 30 days, 6 Months ± 30 days, 12 Months± 30 days
Absence of systemic side effects of verapamil administration
Patients will receive a noncontrast CT scan or MRI approximately 24 hours after intervention to determine the presence or absence of intracerebral hemorrhage (ICH) after intervention.
Time frame: 24-48 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2013 to primary completion in Mar 2016, 37 months.
Of 42 phase 1 interventional studies under Ischemic Stroke, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 37 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Verapamil
Justin Fraser