Ischemic StrokePhase 1SAVER-INCT02235558
Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke
A Phase 1 study testing Verapamil in people with Ischemic Stroke, run by Justin Fraser at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Verapamil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2013to 21 Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- For reference, the TICI Scale is defined below:
- 0 = 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital
Lexington, Kentucky, 40536
About this study
Official title: Super-Selective Intra-Arterial Administration of Verapamil for Neuroprotection After Intra-Arterial Thrombolysis for Acute Ischemic Stroke Phase I Study
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.
Read the detailed description
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.
- Conditions
- Ischemic Stroke
- Being tested
- Verapamil
- Keywords
- Acute Ischemic Stoke, Thrombectomy, Intraarterial Pharmacotherapy, Neuroprotection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Also called Isoptin, Verelan, Verelan PM, Calan
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.
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Experimental | Super-selective intra-arterial administration of 10 mg verapamil immediately following successful intra-arterial thrombolysis Receives: Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-48 hours after treatment
Secondary outcomes (1)
Absence of intracranial hemorrhage
Improved clinical outcomes at followup intervals as measured by the modified Rankin score.
Measured: At follow-up intervals: Day 30 ± 14 days, 3 Months ± 30 days, 6 Months ± 30 days, 12 Months± 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start1 Feb 2013
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justin Fraser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Justin Fraser, University of Kentucky
- Investigators
- Justin F. Fraser, MD, Principal investigator, University of Kentucky Department of Neurological Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235558
- Sponsor's protocol ID
- 12-0975-F1V
- Acronym
- SAVER-I
- Status last verified
- Jan 2017
- First submitted
- 7 Sep 2014
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super-Selective Intra-Arterial Administration of Verapamil for Neuroprotection After Intra-Arterial Thrombolysis for Acute Ischemic Stroke Phase I Study
- ClinicalTrials.gov ID
- NCT02235558
- Acronym / sponsor ID
- SAVER-I / 12-0975-F1V
- Conditions
- Ischemic Stroke
- Keywords
- Acute Ischemic Stoke, Thrombectomy, Intraarterial Pharmacotherapy, Neuroprotection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Justin FraserUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Verapamil | Experimental | Drug: VerapamilSuper-selective intra-arterial administration of 10 mg verapamil immediately following successful intra-arterial thrombolysis |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerapamilAlso: Isoptin, Verelan, Verelan PM, CalanSuper-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. | Drug | Verapamil |
Primary outcome
The primary endpoint will be the presence or absence of intracranial hemorrhage
Time frame: 24-48 hours after treatment
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.
1 secondary outcome
Absence of intracranial hemorrhage
Time frame: At follow-up intervals: Day 30 ± 14 days, 3 Months ± 30 days, 6 Months ± 30 days, 12 Months± 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin F. Fraser, MD principal investigator
University of Kentucky Department of Neurological Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Verapamil in people with Ischemic Stroke, run by Justin Fraser at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the presence or absence of intracranial hemorrhage (time frame: 24-48 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.