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Clinical Trial Details

Trial ID: L6571
Source ID: NCT06085378
Associated Drug: Urinary Kallidinogenase For Injection
Title: Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus
Acronym: TK-SEEK
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Acute Ischemic Stroke|Type 2 Diabetes
Interventions: DRUG: Urinary Kallidinogenase for injection|OTHER: Placebo
Outcome Measures: Primary: The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days, The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days, 90±7 days | Secondary: The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days, The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days, 90±7 days|Distribution of modified rankin scale (mRS) at 90±7 days, Distribution of modified rankin scale (mRS) at 90±7 days, 90±7 days|Changes of NIHSS from baseline to 10 days, Changes of NIHSS from baseline to 10 days, from baseline to day 10|Changes of Barthel index from baseline to 90±7 days, Changes of Barthel index from baseline to 90±7 days, from baseline to day 90±7|Changes of mini-mental state examination (MMSE) from baseline to 90±7 days, Changes of mini-mental state examination (MMSE) from baseline to 90±7 days, from baseline to day 90±7|Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days, Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days, from baseline to day 90±7 | Other: Changes of fasting blood glucose values from baseline to 10 days, Changes of fasting blood glucose values from baseline to 10 days, from baseline to day 10|Changes of HBA1c from baseline to 90±7 days, Changes of HBA1c from baseline to 90±7 days, from baseline to day 90±7|Changes of hypersensitive C-reactive protein (hs-CRP) and interleukin-6 (IL-6), Changes of hypersensitive C-reactive protein (hs-CRP) and interleukin-6 (IL-6), from baseline to day 10|Changes of urea nitrogen, creatinine and urinary protein, Changes of urea nitrogen, creatinine and urinary protein, from baseline to day 10|Stroke recurrence rate within 90 days, Stroke recurrence rate within 90 days, 90 days|Incidence, severity, and causality of adverse events (AE) and serious adverse events (SAE) during the intervention, Incidence, severity, and causality of adverse events (AE) and serious adverse events (SAE) during the intervention, during the intervention
Sponsor/Collaborators: Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 630
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2026-12-31
Results First Posted:
Last Update Posted: 2023-10-16
Locations: The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510080, China
URL: https://clinicaltrials.gov/show/NCT06085378