Superselective Citicoline and Verapamil for Ischemic Neuroprotection and Greater Effective Response

NCT02823106 | Withdrawn Phase 1 DMC

• 1 other identifier: Citicoline and Verapamil
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  within 48 hours after treatment

Secondary Outcomes (1)

• Number of participants who had no systemic side effects from verapamil and citicoline administration.

  within 90 days

Study Arms (2)

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

Drug: Verapamil and Citicoline

Placebo

PLACEBO COMPARATOR

The control group will receive saline only.

Other: Placebo

Interventions

Verapamil and Citicoline DRUG

Single dosing strategy will be used.

Also known as: CDP-choline

Verapamil and Citicoline

Placebo OTHER

Single matching dosing strategy will be used.

Also known as: 0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Justin Fraser: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Verapamil; Cytidine Diphosphate Choline; Sodium Chloride

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; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Justin Fraswer, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 6, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)