Superselective Citicoline and Verapamil for Ischemic Neuroprotection and Greater Effective Response
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 101 |
| Updated: | 7/7/2016 |
| Start Date: | August 2016 |
| End Date: | February 2018 |
| Contact: | Mary Faulkner |
| Email: | mffaul2@uky.edu |
| Phone: | 859-218-5006 |
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.
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.
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.
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.
Inclusion Criteria:
- 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. .
Exclusion Criteria:
- 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
- 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.
We found this trial at
1
site
740 South Limestone Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Principal Investigator: Justin Fraser, MD
Phone: 859-218-5006
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