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

• ClinicalTrials.gov Identifier: NCT02878772
• Recruitment Status: Completed
• First Posted: August 25, 2016
• Last Update Posted: August 25, 2016
• Sponsor: Tianjin Medical University General Hospital
• Information provided by (Responsible Party): Junwei Hao, Tianjin Medical University General Hospital

Tracking Information

• First Submitted Date: August 4, 2016
• First Posted Date: August 25, 2016
• Last Update Posted Date: August 25, 2016
• Study Start Date: May 2014
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2016)

• changes in lesion volume [ Time Frame: lesion volume from baseline to day 7 ]
  changes in lesion volume from baseline (DWI) to day 7 (Flair)
• brain inflammatory level [ Time Frame: day 7 ]
  brain inflammatory level (MRS) at day 7
• extent of clinical improvement [ Time Frame: from baseline to day 7 and 14 ]
  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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 24, 2016)

• probability of excellent recovery [ Time Frame: at day 90 ]
  probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS)
• cytotoxic edema [ Time Frame: day 3 ]
  cytotoxic edema of day 3 (ADC value).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients
• Official Title: Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Stroke
• Immunoregulation
• Inflammation
• 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.
  Other Name: Cavinton
• Drug: Aspirin
  100mg, once daily, oral medication

Study Arms

• Active Comparator: vinpocetine group
  Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
  Interventions:

  • Drug: vinpocetine
  • Drug: Aspirin
• Placebo Comparator: Control group
  Patients will receive aspirin only.
  Intervention: Drug: Aspirin

• Publications *: Zhang F, Yan C, Wei C, Yao Y, Ma X, Gong Z, Liu S, Zang D, Chen J, Shi FD, Hao J. Vinpocetine Inhibits NF-kappaB-Dependent Inflammation in Acute Ischemic Stroke Patients. Transl Stroke Res. 2018 Apr;9(2):174-184. doi: 10.1007/s12975-017-0549-z. Epub 2017 Jul 9.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 24, 2016): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02878772
• Other Study ID Numbers: TianjinMUGH1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Junwei Hao, Tianjin Medical University General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Tianjin Medical University General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tianjin Medical University General Hospital
• Verification Date: August 2016