Verapamil for Neuroprotection in Stroke

Global Neurosciences Institute

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ischemic Stroke

Treatments: Drug: 10 mg Intra-arterial Verapamil; Drug: 20 mg Intra-arterial Verapamil

Study type: Interventional

Funder types: Other

Identifiers

NCT03347786

GNI_verapamil

Details and patient eligibility

About

The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• 18 years of age and over
• Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
• Candidate for mechanical thrombectomy procedure
• Onset of symptoms less than 8 hours
• Measurable neurologic deficit (NIHSS ≥4)
• Willingness to follow up with rehabilitation therapy
• Anticipated life expectancy of at least 3 months

Exclusion criteria

• Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
• Hepatic and/or renal insufficiency (LFT's>3× upper limit of normal; CrCl < 30ml/min)
• Thrombocytopenia (platelet count <75,000/mm3)
• History of intolerance to verapamil
• Previous functional disability (modified Rankin > 1)
• Severe stroke (NIHSS>22)
• Stuporous or comatose
• Unlikely to be available for 90 day follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Verapamil 10 mg Treatment Group

Experimental group

Description:

Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (10 mg) Verapamil.

Treatment:

Drug: 10 mg Intra-arterial Verapamil

Verapamil 20 mg Treatment Group

Experimental group

Description:

Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (20 mg) Verapamil.

Treatment:

Drug: 20 mg Intra-arterial Verapamil