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Table 1 Outcome evaluation time points

From: Efficacy and safety of lumbrokinase plus aspirin versus aspirin alone for acute ischemic stroke (LUCENT): study protocol for a multicenter randomized controlled trial

Time

Screening period

Baseline stage

Period of drug treatment(90d)

Follow-up

− 72 h

D0

D14 ± 3 days

D28 ± 3 days

D60 ± 3 days

D90 ± 3 days

D180 ± 7 days

Visit date

X

X

X

X

X

X

X

Inclusion/exclusion criteria

X

      

Informed consent

X

      

Demographic data

X

      

Vital signs and physical examination

X

X

X

X

X

X

 

History of malignant tumor and aneurysm

X

      

Family history, medical history and treatment history of TIA, Stroke, hemorrhagic disease

X

      

Previous history of disease

X

      

Allergic history

X

      

History of tobacco and alcohol

 

X

     

Routine blood

 RBC

 

X

   

X

 

 WBC

 

X

   

X

 

 Neutrophil

 

X

   

X

 

 Lymphocyte

 

X

   

X

 

 PLT

 

X

   

X

 

 Hb

 

X

   

X

 

 PCV

 

X

   

X

 

Urinalysis

 U-LEU

 

X

X

X

X

X

 

 U-BLD

 

X

X

X

X

X

 

 R-PRO

 

X

X

X

X

X

 

 U-Ket

 

X

X

X

X

X

 

Routine stool

 OB

X

    

X

 

Liver function and kidney function

 ALT

X

 

X

X

X

X

 

 AST

X

 

X

X

X

X

 

 TBil

X

 

X

X

X

X

 

 BUN

X

 

X

X

X

X

 

 Scr

X

 

X

X

X

X

 

Fasting lipid panel

 TC

 

X

   

X

 

 TG

 

X

   

X

 

 HDL

 

X

   

X

 

 LDL

 

X

   

X

 

 Fasting blood glucose

 

X

   

X

 

Coagulation function

 PT

 

X

X

X

X

X

 

 APTT

 

X

X

X

X

X

 

 FIB

 

X

X

X

X

X

 

 hs-CRP

 

X

   

X

 

 Homocysteine

X

      

 ECG

X

    

X

 

 MRI of brain

X

    

X

 

 ADL scale (BI)

 

X

   

X

X

 NIHSS

X

 

X

X

X

X

 

 mRS before stroke

X

      

 mRS

 

X

X

X

X

X

X

 Recurrence rate

  

X

X

X

X

X

 Cardiovascular and cerebrovascular events

  

X

X

X

X

X

 Bleeding event

  

X

X

X

X

 

 Mortality rate

  

X

X

X

X

X

 AE and SAE

 

X

X

X

X

X

 

 Combined use of drugs

 

X

X

X

X

X

 

 Adherence evaluation

  

X

X

X

X

 
  1. Abbreviations: TIA, transient ischaemic attack; RBC, erythrocyte count; WBC, leukocyte count; PLT, blood platelet; Hb, hemoglobin; PCV, packed cell volume; U-LEU, urine leukocyte; U-BLD, urine latent blood; R-PRO, urine protein; U-Ket, urine ketone bodies; OB, fecal occult blood; ALT, alanine aminotransferase; AST, aspartate aminotransferase; TBil, total bilirubin; BUN, blood urea nitrogen; Scr, serum creatinine; TC, total cholesterol; TG, triglyceride; HDL, high-density lipoprotein; LDL, low-density lipoprotein; PT, prothrombin time; APTT, activated partial thromboplastin time; FIB, fibrinogen; hs-CRP, hypersensitive C-reactive protein; ECG, electrocardiogram; MRI, magnetic resonance imaging; ADL, activity of daily living; BI, Barthel Index; NIHSS, National Institutes of Health Stroke Scale; mRS, Modified Rankin Scale; AE, adverse event; SAE, serious adverse event