Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients

Stroke Clinical Trial

Official title:

Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878772
• Other study ID #: TianjinMUGH1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 4, 2016
• Last updated: August 24, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Tianjin Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. For this multi-center study, investigators recruited 60 patients with anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but lasted less than 48 hours. These patients, after randomly division into two groups, received either standard management alone (controls) or standard management plus vinpocetine (30 mg per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• >18 years of age

• Anterior-circulation ischemic stroke: All patients had symptoms of focal neurological deficits and simultaneous radiological evidence (magnetic resonance imaging, MRI) of an ischemic brain lesion

• measurable neurological deficit (NIHSS > 5)

• interval between symptom onset and admission more than 4.5 hours and less than 48 hours. That is, all patients we recruited were beyond the 4.5 hours of symptom onset and, therefore, past the accepted time-window for thrombolytic therapy

Exclusion Criteria:

• hemorrhagic stroke and severe hemorrhage in other organs

• other diseases of the central nervous system (CNS)

• diabetes mellitus

• tumor or hematological systemic diseases

• any infection before acute ischemic stroke

• concomitant use of antineoplastic or immune modulating therapies

• contraindication to MRI

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunoregulation
• Inflammation
• Stroke
• Vinpocetine

Intervention

Drug:
• vinpocetine
30 mg of the drug by intravenous infusion once daily, for fourteen consecutive days, beginning within one hour after the baseline MRI and no later than 48 hours after the onset of symptoms.
• Aspirin
100mg, once daily, oral medication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in lesion volume	changes in lesion volume from baseline (DWI) to day 7 (Flair)	lesion volume from baseline to day 7	Yes
Primary	brain inflammatory level	brain inflammatory level (MRS) at day 7	day 7	Yes
Primary	extent of clinical improvement	extent of clinical improvement at day 7 and 14, as measured by the changes on the NIHSS score from baseline to day 7 and 14	from baseline to day 7 and 14	No
Secondary	probability of excellent recovery	probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS)	at day 90	No
Secondary	cytotoxic edema	cytotoxic edema of day 3 (ADC value).	day 3	No