Coronary Artery Disease
Conditions
Interventions
ASA group:aspirin, 100mg daily
PNS gruop:Xuesaitong soft capsules, 2 tablets each time, twice daily
combination gruop:aspirin(100mg daily) combined with Xuesaitong soft capsules(2 tablets each time, twice daily)
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) with concomitant diagnosis of stable coronary artery disease (SCAD) and chronic superficial gastritis (CSG); (2) of Han nationality; (3) aged 40-65 years; (4) with documented percutaneous coronary intervention beyond 1 year prior to the trial; (5) with blood-stasis syndrome; (6) helicobacter pylori(+). SCAD will be diagnosed according to "2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease" and "2013 ESC guidelines on the management of stable coronary artery disease". Chronic superficial gastritis will be endoscopically confirmed.
Exclusion criteria
Exclusion criteria: (1) allergy to aspirin or PNS or any ingredients of them; (2) personal or family medical history of hemorrhagic disorders; (3) platelet count<100×10^9/L or 450×10^9/L; (4) hemoglobin<90 g/L; (5) medical history of gastrointestinal ulcer or bleeding, erosive esophagitis, esophageal varices; (6) current gastrointestinal ulcer or bleeding or severe gastrointestinal symptoms required for anti-ulcer agents; (7)the presence of uncontrolled blood pressure(a systolic blood pressure =160 mmHg or a diastolic blood pressure =100 mmHg); heart failure with New York Heart Association (NYHA) functional class IV or ejection fraction <35%; severe arrhythmia affecting hemodynamic stability; acute cerebrovascular disease; severe pulmonary dysfunction; severe hepatic, renal, hematologic or mental disorders; malignancy; (8) medication history of antiplatelet drugs, anticoagulants, corticosteroids, proton pump inhibitors, prostaglandin analogue, H2-receptor antagonist (H2RA), sucralfate, herbal medicine with effect of activating blood and removing stasis during the 14 days before enrollment; (9) trauma or surgery during the 14 days before enrollment; (10) Pregnancy or lactation; (11) participation in other clinical trials; (12) refuse to sign the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelet aggregation rate;gastroscopy;metabolites in AA metabolic pathway; | — |
Secondary
| Measure | Time frame |
|---|---|
| coagulation function test;Seattle Angina Questionnaire;CAD blood stasis score;severity of dyspepsia assessment(SODA); | — |
Countries
China
Contacts
Public ContactShi Dazhuo
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed