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Table 1 Measurement items and points of data capture

From: Effect of Xinyue capsules on patients with coronary heart disease after percutaneous coronary intervention: study protocol for a randomized controlled trial

 

Screening

Treatment period

Follow-up period

Visit 1

Run-in period (visit 2)

12 weeks (visit 3)

24 weeks (visit 4)

12 weeks (visit 5)

24 weeks (visit 6)

Informed consent

X

     

Inclusion/exclusion criteria

 

X

    

Demographic data

X

     

Medical history

X

     

Concomitant medications

X

     

Tongue and pulse condition in TCM

X

X

X

X

X

X

Vital signs

X

X

X

X

X

X

12-lead ECG

X

  

X

 

X

Complete blood count, urine and stool tests

X

  

X

 

X

Liver and renal function tests

X

  

X

 

X

Coagulation function test

X

  

X

 

X

Adverse event evaluation

  

X

X

X

X

Dispense drug

 

X

X

X

X

X

Primary endpoint

  

X

X

X

X

Secondary endpoint

  

X

X

X

X

Cardiac function

X

  

X

 

X

hs-CRP

X

  

X

 

X

Lipid panels

X

  

X

 

X

QLR score

X

 

X

X

X

X

SF-36 score

X

 

X

X

X

X

TCM syndrome score

X

 

X

X

X

X

  1. Abbreviations: ECG electrocardiogram, hs-CRP high-sensitivity C-reactive protein, SF36 36-item Short Form Health Survey, TCM traditional Chinese medicine, QLQ quality of Life Questionnaire​
  2. X represents the indicators tested in the specific time period
  3. Coagulation function test: prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time
  4. Lipid panels: high-density lipoprotein, low-density lipoprotein, cholesterol, triglycerides
  5. Primary endpoint: time from randomization to the first occurrence of the major adverse cardiovascular event
  6. Secondary endpoint: time from randomization to the first occurrence of stroke, pulmonary embolism, and peripheral vascular events, as well as death due to any cause
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Trials

ISSN: 1745-6215