A Phase 1 interventional study of Verapamil and Citicoline and Placebo in Ischemic Stroke, sponsored by Justin Fraser. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 101 Years. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Justin Fraser · Phase 1, Interventional, and Treatment
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.
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):
Visit 2 - Within 48 hours of admission
Visit 3 - ( By Discharge)
Visit 4 - End of Study (90 Days) (+/- 30 days)
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Verapamil and Citicoline
The control group will receive saline only.
Other: Placebo
Drug pages: Verapamil · Cytidine Diphosphate Choline
Single dosing strategy will be used.
Also known as: CDP-choline
Single matching dosing strategy will be used.
Also known as: 0.9% sodium chloride
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.
Time frame: within 48 hours after treatment
Number of participants who had no systemic side effects from verapamil and citicoline administration.
At any point during study treatment
Time frame: within 90 days
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Aug 2016, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Verapamil · Cytidine Diphosphate Choline
Justin Fraser