coronary heart disease and gastrointestinal diseases
Conditions
Interventions
clopidogrel combined with rivaroxaban arm:clopidogrel combined with rivaroxaban
clopidogrel combined with aspirin arm:clopidogrel combined with aspirin
Sponsors
General Hospital of Northern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patient aged from 18 to 75 years; 2.Patient presents with Non-ST-segment elevation acute coronary syndrome (NSTEMI) combined with GRACE score < 140 points or stable coronary artery disease (SCAD); 3.Patient has gastrointestinal diseases (Gastrointestinal diseases are defined as acute or chronic gastritis, erosive gastritis, gastrointestinal bleeding or peptic ulcer healing for 1-12 months, gastrointestinal dysfunction diagnosed by a specialist, and gastrointestinal tumor to be operated on); 4.Patient with gastrointestinal bleeding or ulcer in the past one year ago has stomach pain, abdominal distension or other discomfort after taking aspirin, but they can tolerate it; 5.Patient voluntarily signs informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patient presents with Non-ST-segment elevation acute coronary syndrome (NSTEMI) combined with GRACE score > 140 points or ST-segment elevation acute myocardial infarction (STEMI); 2. Patient with intracranial hemorrhage (within one month) or bleeding of important organs; 3. Platelet count 3 ULN or AST > 3 ULN; 6. Patient with severe renal insufficiency (eGFR <30ml/min/1.73m2 based on simplified MDRD equation or CrCl <30ml/min based on Cockcroft-Gault equation); 7. Patient with active stage of digestive tract ulcer; 8. Patient with less weight (Weight less than 45kg); 9. Allergic to aspirin or rivaroxaban; 10. Patient has no intention of PCI treatment; 11. Patient has a malignancy or a life expectancy of less than one year; 12. Patient is pregnant, breastfeeding, or planning to become pregnant within 6 months; 13. Patient should take potent CYP3A4 inhibitors and p–gp inhibitors for a long time(such as Ketoconazole, voriconazole, nefazodone, erythromycin); 14. Patient should take medium and strong CYP2C19 inhibitors (such as omeprazole, esomeprazole, fluconazole, etc.) or CYP2C19 inducers (such as rifampicin) which are known to interact with clopidogrel for a long time; 15. Patient is not expected to tolerate 6 months of medication; 16. Not suit for participate the study; 17. Patient is participating in other ongoing clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| moderate and serve bleeding events (BARC 2-5); | — |
Secondary
| Measure | Time frame |
|---|---|
| main adverse cardiovascular and cerebrovascular events (MACCE); | — |
Countries
China
Contacts
Public ContactXiaozeng Wang
General Hospital of Northern Theater Command
Outcome results
None listed