Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke

NCT02235558 | Completed Phase 1 FDA Drug

• 1 other identifier: 12-0975-F1V
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Acute Ischemic Stoke; Thrombectomy; Intraarterial Pharmacotherapy; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• 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.

  24-48 hours after treatment

Secondary Outcomes (1)

• Absence of intracranial hemorrhage

  At follow-up intervals: Day 30 ± 14 days, 3 Months ± 30 days, 6 Months ± 30 days, 12 Months± 30 days

Other Outcomes (1)

• Absence of systemic side effects of verapamil administration

  24-48 hours

Study Arms (1)

Verapamil

EXPERIMENTAL

Super-selective intra-arterial administration of 10 mg verapamil immediately following successful intra-arterial thrombolysis

Drug: Verapamil

Interventions

Verapamil DRUG

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

Verapamil

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 21-85 years old, male or female
• Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
• Patients must meet criteria for intra-arterial thrombolysis as determined and documented by Interventional Neuroradiology attending physician (JF or AA).
• Patients must have an acute thromboembolus within an intracranial artery (internal carotid, anterior cerebral, middle cerebral, posterior cerebral, basilar, vertebral) which undergoes pharmacologic (tissue plasminogen activator - tPA) and/or mechanical (eg. Merci or Penumbra clot retrieval) thrombolysis.
• Patients with impaired capacity may be included, as the pathology to be studied (stroke) may impair their capacity (please see attached required documentation regarding impaired capacity).
• Patients must have a TICI 2A or better revascularization via intra-arterial thrombolysis.
• For reference, the TICI Scale is defined below:
• = No Perfusion
• = Perfusion past the initial obstruction but limited distal branch filling with little or slow distal perfusion
• A = Perfusion of less than 50% of the vascular distribution of the occluded artery
• B = 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

You may not qualify if:

• Pregnant women (would not qualify for intra-arterial thrombolysis as standard of care).
• Patients who undergo intra-arterial thrombolysis for acute stroke, in whom only TICI 0 or 1 revascularization is obtained.
• Patients with occlusion of the cervical common or internal carotid artery will be excluded from the study.

Sponsors & Collaborators

• Justin Fraser: lead

Study Sites (1)

University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Justin F. Fraser, MD

  University of Kentucky Department of Neurological Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst Professor of Cerebrovascular, Endovascular, and Skull Base Surgery; Departments of Neurological Surgery, Neurology, Radiology, and Anatomy & Neurobiology

Study Record Dates

• First Submitted: September 7, 2014
• First Posted: September 10, 2014
• Study Start: February 1, 2013
• Primary Completion: March 21, 2016
• Study Completion: March 21, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)