Research Article

Combination of Xuesaitong and Aspirin Based on the Antiplatelet Effect and Gastrointestinal Injury: Study Protocol for a Randomized Controlled Noninferiority Trial

Table 2

Inclusion, exclusion, and termination criteria.

Criteria

Inclusion criteria
(1) 45–75 years of age without gender restriction
(2) Meet the diagnostic criteria of CHD
(3) Meet the diagnostic criteria of grade I–II angina
(4) Meet the diagnostic criteria of blood stasis
(5) Meet the diagnostic criteria of stable angina pectoris
(6) Take regular aspirin (enteric-coated) for at least one year (the incidence of bleeding events, adverse events (AEs), and adverse reactions will be noted)
(7) Calprotectin in stool is above 50 μg/g
(8) Before the study start, patients and their families are fully informed and voluntarily willing to sign an informed consent

Exclusion criteria
(1) Mental or physical disorders
(2) Pregnant, menstruating, and breastfeeding women
(3) Severe heart disease and severe cardiopulmonary dysfunction
(4) Severe primary diseases, such as cancer, liver and renal damage, and multiple organ failure
(5) Poorly controlled hypertension (>160/100 mmHg)
(6) Current participation in another clinical trial or participation in another clinical trial within three months
(7) Having underwent surgery within eight weeks
(8) Having drug allergy history or allergic constitution
(9) Diabetes
(10) Status epilepticus
(11) Unstable vital signs
(12) Combined with serious infection, infectious diseases
(13) Acute intestinal infection
(14) Unsuitability or poor compliance for this trial

Termination criteria
 Participant termination
  (1) Serious adverse events occur or having obvious abnormal value of the laboratory tests
  (2) The investigators believe someone’s trial needs to be terminated because of medical, safety, or GCP considerations
 Trial termination
  (1) Half of the participants have mild adverse events other than gastrointestinal reactions
  (2) The investigators believe it is necessary to abort the trial for medical or safety purposes