Ischemic StrokePhase 1SCAVINGERNCT02823106
Superselective Citicoline and Verapamil for Ischemic Neuroprotection and Greater Effective Response
A Phase 1 study testing Verapamil and Citicoline in people with Ischemic Stroke, run by Justin Fraser at 1 site in United States.
Trial summary
This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the safety and feasibility of super-selective intra-arterial administration of verapamil and citicoline immediately following successful endovascular thrombectomy as a potential neuroprotective synergistic therapeutic strategy in… Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Verapamil and Citicoline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 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 18 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent and HIPAA form. Participants with impaired capacity may be included provided a Legally Authorized Representative as recognized by the the State of Kentucky, signs the informed consent.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years or older
- Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
- Participants must meet criteria for intra-arterial thrombectomy as determined and documented by Interventional Neuroradiology attending physician at University of Kentucky.
- Participants must have an acute thromboembolus within an intracranial artery in the anterior circulation (internal carotid, anterior cerebral, middle cerebral), which undergoes mechanical thrombectomy.
- Participant must have a TICI 2B or better revascularization via thrombectomy.
- For females of reproductive potential a negative pregnancy test at baseline is required. .
Who cannot join
- Pregnant/lactating women
- Therapeutic anticoagulation prior to admission as it is a relative contraindication to thrombectomy
- Participants who undergo intra-arterial thrombectomy for acute stroke, in whom only TICI 0-2A revascularization is obtained.
- Known allergic reactions to components of Verapamil or Citicoline.
- Verapamil should not be given to individuals who have a serious heart condition such as:
- sick sinus syndrome or AV block
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- severe heart failure;
- fainting do to slow heartbeats
- certain heart rhythm disorders of the atrium (excluding atrial fibrillation)
- active congestive heart failure;
- low blood pressure;
- a nerve-muscle disorder such as myasthenia gravis or muscular dystrophy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
Official title: Superselective Citicoline And Verapamil for Ischemic Neuroprotection and Greater Effective Response (SCAVINGER) in the Kentucky Regional Population: A Clinical and Translational Study
This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the safety and feasibility of super-selective intra-arterial administration of verapamil and citicoline immediately following successful endovascular thrombectomy as a potential neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke. This trial represents the first time that citicoline will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to evaluate combinational therapy for acute stroke neuroprotection.
Read the detailed description
Participants will be recruited from patients evaluated at University of Kentucky Chandler Hospital for acute ischemic stroke. Participants with impaired capacity may be included, as the pathology to be studied (stroke) may impair their capacity. Initial contact will be made by the sub-investigators approved to obtain consent; all sub-investigators are practitioners who would make contact with potential participants in a clinical manner under standard clinical procedures. All sub-investigators will have access to stroke patients' medical information under normal circumstances. No special outreach is necessary to recruit particular populations. Enrollment goal will be 15 patients in each group.
Participants will not be compensated or provided any incentives for study participation.
The following describes all study procedures and evaluations that are to be done as part of the study.
Visit 1-Baseline (Day 0):
- Obtain consent.
- Medical history taken from medical record, participant and family to determine eligibility based on inclusion/exclusion criteria (Standard of Care)
- Medication history (Standard of Care)
- Physical examination to include vital signs (Standard of Care)
- Pregnancy Testing (Standard of Care)
- NIH Stroke Scale (Standard of Care)
- Verify inclusion/exclusion criteria
- Randomization
- Cerebral angiogram with Endovascular Thrombectomy (Standard of Care)
- Study Drug administration
- Adverse event (AE) collection
Visit 2 - Within 48 hours of admission
- Non-contrast Postoperative MRI or CT (Standard of Care) 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.
Visit 3 - ( By Discharge)
- NIH Stroke Scale (Standard of Care)
- Discharge Destination (Standard of Care)
- Cognitive Assessment (Standard of Care)
- Radiographic assessment of primary and secondary radiologic endpoints
Visit 4 - End of Study (90 Days) (+/- 30 days)
- UBACC assessment will be used to assess consent capacity at follow-up.
- Montreal Cognitive Assessment (MoCA)
- Modified Rankin Score (mRS; Standard of Care)
The visit may be conducted over the phone with the participant or their legally authorized representative.
Unscheduled Visits. It is unexpected that Unscheduled Visits will be common, especially with the follow-up within 90 days after the procedure. However, subjects readmitted to the hospital for any reason will be tracked to determine if an AE occurred.
There are no particular prohibited medications, treatments, or procedures for after administration of the study drug. However, therapeutic anticoagulation is a relative contraindication to thrombectomy. Patients on therapeutic anticoagulation will be excluded from the study.
Following successful completion of the baseline visit, participants will be randomized into the study. The randomization number will be assigned by the PI/neurointerventionalist.
Participants will be randomized to receive 10mg of verapamil in 10 cc of normal saline and 1000mg of citicoline in 10cc of normal saline or matching placebo.
- Conditions
- Ischemic Stroke
- Being tested
- Verapamil and Citicoline, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verapamil and CiticolineDrug
Also called CDP-choline
Single dosing strategy will be used.
PlaceboOther
Also called 0.9% sodium chloride
Single matching dosing strategy will be used.
| Study group | Role | What they receive |
|---|---|---|
| Verapamil and Citicoline | Experimental | 10mg of verapamil in 10 cc of normal saline and 1000mg of citicoline in 10cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot to the treatment group Receives: Drug: Verapamil and Citicoline |
| Placebo | Placebo comparator | The control group will receive saline only. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants having no symptomatic intracranial hemorrhage
Defined as a hemorrhage occurring within 48 hours after study inclusion, temporally related to the intervention, and occurring with worsening neurological status as documented in the clinical exam.
Measured: within 48 hours after treatment
Secondary outcomes (1)
Number of participants who had no systemic side effects from verapamil and citicoline administration.
At any point during study treatment
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Study put on clinical hold by FDA. Sponsor decided to no pursue the study.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 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 Fraswer, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823106
- Sponsor's protocol ID
- Citicoline and Verapamil
- Acronym
- SCAVINGER
- Status last verified
- Sep 2016
- First submitted
- 24 Jun 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superselective Citicoline And Verapamil for Ischemic Neuroprotection and Greater Effective Response (SCAVINGER) in the Kentucky Regional Population: A Clinical and Translational Study
- ClinicalTrials.gov ID
- NCT02823106
- Acronym / sponsor ID
- SCAVINGER / Citicoline and Verapamil
- Conditions
- Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study put on clinical hold by FDA. Sponsor decided to no pursue the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Justin FraserUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Jul 2016 (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.
This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the safety and feasibility of super-selective intra-arterial administration of verapamil and citicoline immediately following successful endovascular thrombectomy as a potential neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke. This trial represents the first time that citicoline will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to evaluate combinational therapy for acute stroke neuroprotection.
Detailed description
Participants will be recruited from patients evaluated at University of Kentucky Chandler Hospital for acute ischemic stroke. Participants with impaired capacity may be included, as the pathology to be studied (stroke) may impair their capacity. Initial contact will be made by the sub-investigators approved to obtain consent; all sub-investigators are practitioners who would make contact with potential participants in a clinical manner under standard clinical procedures. All sub-investigators will have access to stroke patients' medical information under normal circumstances. No special outreach is necessary to recruit particular populations. Enrollment goal will be 15 patients in each group.
Participants will not be compensated or provided any incentives for study participation.
The following describes all study procedures and evaluations that are to be done as part of the study.
Visit 1-Baseline (Day 0):
- Obtain consent.
- Medical history taken from medical record, participant and family to determine eligibility based on inclusion/exclusion criteria (Standard of Care)
- Medication history (Standard of Care)
- Physical examination to include vital signs (Standard of Care)
- Pregnancy Testing (Standard of Care)
- NIH Stroke Scale (Standard of Care)
- Verify inclusion/exclusion criteria
- Randomization
- Cerebral angiogram with Endovascular Thrombectomy (Standard of Care)
- Study Drug administration
- Adverse event (AE) collection
Visit 2 - Within 48 hours of admission
- Non-contrast Postoperative MRI or CT (Standard of Care) 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.
Visit 3 - ( By Discharge)
- NIH Stroke Scale (Standard of Care)
- Discharge Destination (Standard of Care)
- Cognitive Assessment (Standard of Care)
- Radiographic assessment of primary and secondary radiologic endpoints
Visit 4 - End of Study (90 Days) (+/- 30 days)
- UBACC assessment will be used to assess consent capacity at follow-up.
- Montreal Cognitive Assessment (MoCA)
- Modified Rankin Score (mRS; Standard of Care)
The visit may be conducted over the phone with the participant or their legally authorized representative.
Unscheduled Visits. It is unexpected that Unscheduled Visits will be common, especially with the follow-up within 90 days after the procedure. However, subjects readmitted to the hospital for any reason will be tracked to determine if an AE occurred.
There are no particular prohibited medications, treatments, or procedures for after administration of the study drug. However, therapeutic anticoagulation is a relative contraindication to thrombectomy. Patients on therapeutic anticoagulation will be excluded from the study.
Following successful completion of the baseline visit, participants will be randomized into the study. The randomization number will be assigned by the PI/neurointerventionalist.
Participants will be randomized to receive 10mg of verapamil in 10 cc of normal saline and 1000mg of citicoline in 10cc of normal saline or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil and Citicoline | Experimental | Drug: Verapamil and Citicoline10mg of verapamil in 10 cc of normal saline and 1000mg of citicoline in 10cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot to the treatment group |
| Placebo | Placebo comparator | Other: PlaceboThe control group will receive saline only. |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent and HIPAA form. Participants with impaired capacity may be included provided a Legally Authorized Representative as recognized by the the State of Kentucky, signs the informed consent.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years or older
- Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
- Participants must meet criteria for intra-arterial thrombectomy as determined and documented by Interventional Neuroradiology attending physician at University of Kentucky.
Key exclusion criteria (12 listed)
- Pregnant/lactating women
- Therapeutic anticoagulation prior to admission as it is a relative contraindication to thrombectomy
- Participants who undergo intra-arterial thrombectomy for acute stroke, in whom only TICI 0-2A revascularization is obtained.
- Known allergic reactions to components of Verapamil or Citicoline.
- Verapamil should not be given to individuals who have a serious heart condition such as:
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 |
|---|---|---|
| Verapamil and CiticolineAlso: CDP-cholineSingle dosing strategy will be used. | Drug | Verapamil and Citicoline |
| PlaceboAlso: 0.9% sodium chlorideSingle matching dosing strategy will be used. | Other | Placebo |
Primary outcome
Number of participants having no symptomatic intracranial hemorrhage
Time frame: within 48 hours after treatment
Defined as a hemorrhage occurring within 48 hours after study inclusion, temporally related to the intervention, and occurring with worsening neurological status as documented in the clinical exam.
1 secondary outcome
Number of participants who had no systemic side effects from verapamil and citicoline administration.
Time frame: within 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: No
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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 Fraswer, MD principal investigator
University of Kentucky
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 and Citicoline 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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 23 Sep 2016. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants having no symptomatic intracranial hemorrhage (time frame: within 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 Sep 2016.