Rivaroxaban or Aspirin in Patients With CHD & GD Undergoing PCI

NCT04805710 | Unknown Phase 4 DMC

• 1 other identifier: ShenyangNH
• Study Type: interventional
• Target: 1,020
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rivaroxaban

Outcome Measures

Primary Outcomes (1)

• Occurrence of moderate and serve bleeding events which is identified by Bleeding Academic Research Consortium (BARC)

  Bleeding Academic Research Consortium (BARC)

  6 months

Secondary Outcomes (1)

• Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)

  6 months

Study Arms (2)

clopidogrel combined with aspirin arm

NO INTERVENTION

Patients selected in the clopidogrel combined with aspirin arm will receive clopidogrel 75 mg once daily and aspirin 100 mg once daily.

clopidogrel combined with rivaroxaban arm

EXPERIMENTAL

Patients selected in the clopidogrel combined with rivaroxaban arm will receive clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily.

Drug: clopidogrel combined with rivaroxaban arm

Interventions

clopidogrel combined with rivaroxaban arm DRUG

Patients who have been selected will be randomized to the clopidogrel combined with rivaroxaban arm. clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily

Also known as: clopidogrel combined with rivaroxaban

clopidogrel combined with rivaroxaban arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of cardiology, Shenyang Northern Hospital

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: March 17, 2021
• Primary Completion: September 16, 2022
• Study Completion: December 31, 2023
• Last Updated: March 18, 2021

Record last verified: 2021-03