Superselective Citicoline and Verapamil for Ischemic Neuroprotection and Greater Effective Response

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT02823106

Run by

Justin Fraser

People needed

0

Starts

2016-08-01

Expected to finish

2016-09-01

Last updated by the study team

2016-09-23

Who can join

Age: 18 and older, up to 101. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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