Rivaroxaban or Aspirin in Patients With CHD & GD Undergoing PCI

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess the efficacy and safety of rivaroxaban or aspirin combined with clopidogrel in patients with coronary heart disease and gastrointestinal diseases undergoing PCI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenyang Northern Hospital
• Treatments: Clopidogrel; Rivaroxaban

Criteria

Inclusion Criteria:

• Patient aged from 18 to 75 years

• Patient presents with Non-ST-segment elevation acute coronary syndrome (NSTEMI) combined with GRACE score < 140 points or stable coronary artery disease (SCAD)

• 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)

• 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

• Patient voluntarily signs informed consent form

Exclusion Criteria:

• 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)

• Patient with intracranial hemorrhage (within one month) or bleeding of important organs or other than recent surgery for gastrointestinal tumors

• Platelet count <100 000/μL

• Hemoglobin <100g/L

• Patient with active liver diseases or ALT >3 × the upper limit of the normal range or AST>3 × the upper limit of the normal range

• Patient with severe renal insufficiency (eGFR <30ml/min/1.73m2 based on simplified MDRD equation or CrCl <30ml/min based on Cockcroft-Gault equation)

• Patient with active stage of digestive tract ulcer

• Patient with less weight （Weight less than 45kg）

• Allergic to aspirin or rivaroxaban

• Patient has no intention of PCI treatment

• Patient has a malignancy or a life expectancy of less than six months

• Patient is pregnant, breastfeeding, or planning to become pregnant within 6 months

• Patient should take potent CYP3A4 inhibitors and p-gp inhibitors for a long time(such as Ketoconazole, voriconazole, nefazodone, erythromycin)

• 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

• Patient is not expected to tolerate six months of medication

• No informed consent can be obtained or any situation that the researcher thinks is not suitable for participating in this study

• Patient is participating in other ongoing clinical studies