Superselective Citicoline and Verapamil for Ischemic Neuroprotection and Greater Effective Response

• Status: Withdrawn
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Justin Fraser
• Treatments: Choline; Cytidine Diphosphate Choline; Verapamil

Criteria

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.