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

Table 1

Flowchart of a patient follow-up

Group	Screening D-7 to D1	D1	D30	D31 closeout
Patient information	X
Physical examination	X	X		X
Vital signs	X			X
Blood routine; serum biochemistry; urine routine; stool routine; coagulation routine	X^1	X^1		X^1
ECG	X			X
Stool biomarkers (calprotectin; I-FABP)		X	X
Blood biomarkers (platelet aggregation; P2Y12; PAC-1; P-selectin)		X	X

D: day; ECG: electrocardiogram; I-FABP: intestinal fatty acid-binding protein; PAC-1: platelet-associated complement 1. ¹If the abnormality of this program is clinically significant, if it occurs before screening and at baseline, the subjects will be excluded directly. If it occurs during the observation period of administration, the retest will be followed up until the examination is normal or the abnormality is considered by the study doctor to be of no clinical significance.