RivaroxabanPhase 4NCT04805710
Rivaroxaban or Aspirin in Patients With CHD & GD Undergoing PCI
A Phase 4 study testing clopidogrel combined with rivaroxaban arm in people with Rivaroxaban, run by Shenyang Northern Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rivaroxaban
- What is being tested?
- clopidogrel combined with rivaroxaban arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
Official title: The Efficacy and Safety of Clopidogrel Combined With Rivaroxaban and Aspirin in Patients With Coronary Heart Disease and Gastrointestinal Diseases Undergoing PCI：a Randomized Controlled Study
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.
Read the detailed description
Background：Aspirin combined with P2Y12 receptor antagonist are the antithrombotic basis of percutaneous coronary intervention (PCI) for coronary heart disease. Guidelines at home and abroad recommend that patients with stable coronary heart disease need double antiplatelet therapy for 6 months, and patients with acute coronary syndrome need double antiplatelet therapy for 12 months to prevent stent thrombosis and reduce the risk of ischemic or atherosclerotic thrombosis events, including stent thrombosis, recurrent myocardial infarction and cardiogenic death. Aspirin can inhibit the activity of cyclooxygenase in gastrointestinal tract, causing gastrointestinal mucosal epithelial injury and bleeding. For patients with gastrointestinal diseases, the risk of bleeding is higher after taking aspirin for a long time. 48.7% of PCI patients suffered from bleeding in digestive tract, so it is very important to protect gastrointestinal mucosa. In the past, patients with coronary heart disease who were accompanied by gastrointestinal diseases and could not tolerate aspirin often delayed PCI or conservative treatment with drugs, and the prognosis was very poor. In the study of patients with coronary heart disease complicated with atrial fibrillation undergoing PCI, it is concluded that the bleeding rate in the clopidogrel combined with rivaroxaban group is lower and the curative effect is not inferior to that of triple antithrombotic regimen. Whether rivaroxaban can replace aspirin for coronary heart disease complicated with gastrointestinal diseases has no research evidence and no relevant guidelines.
Methods:Patients who have been selected will be randomized to the clopidogrel combined with rivaroxaban arm versus the clopidogrel combined with aspirin arm. Patients selected in the clopidogrel combined with rivaroxaban arm will receive clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily. Patients selected in the clopidogrel combined with aspirin arm will receive clopidogrel 75 mg once daily and aspirin 100 mg once daily. The therapy will last for at least six months in the both arms. The primary endpoints will be evaluated at six-months follow-up.
- Conditions
- Rivaroxaban
- Being tested
- clopidogrel combined with rivaroxaban arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel combined with rivaroxaban armDrug
Also called clopidogrel combined with rivaroxaban
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: clopidogrel combined with rivaroxaban arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of moderate and serve bleeding events which is identified by Bleeding Academic Research Consortium (BARC)
Bleeding Academic Research Consortium (BARC)
Measured: 6 months
Secondary outcomes (1)
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
MACCE will include all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI) and ischemia driven revascularization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start17 Mar 2021 (estimated)
- Primary completion16 Sep 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RivaroxabanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805710
- Sponsor's protocol ID
- ShenyangNH
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Clopidogrel Combined With Rivaroxaban and Aspirin in Patients With Coronary Heart Disease and Gastrointestinal Diseases Undergoing PCI：a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04805710
- Acronym / sponsor ID
- ShenyangNH
- Conditions
- Rivaroxaban
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 17 Mar 2021 (estimated)
- Primary completion
- 16 Sep 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background：Aspirin combined with P2Y12 receptor antagonist are the antithrombotic basis of percutaneous coronary intervention (PCI) for coronary heart disease. Guidelines at home and abroad recommend that patients with stable coronary heart disease need double antiplatelet therapy for 6 months, and patients with acute coronary syndrome need double antiplatelet therapy for 12 months to prevent stent thrombosis and reduce the risk of ischemic or atherosclerotic thrombosis events, including stent thrombosis, recurrent myocardial infarction and cardiogenic death. Aspirin can inhibit the activity of cyclooxygenase in gastrointestinal tract, causing gastrointestinal mucosal epithelial injury and bleeding. For patients with gastrointestinal diseases, the risk of bleeding is higher after taking aspirin for a long time. 48.7% of PCI patients suffered from bleeding in digestive tract, so it is very important to protect gastrointestinal mucosa. In the past, patients with coronary heart disease who were accompanied by gastrointestinal diseases and could not tolerate aspirin often delayed PCI or conservative treatment with drugs, and the prognosis was very poor. In the study of patients with coronary heart disease complicated with atrial fibrillation undergoing PCI, it is concluded that the bleeding rate in the clopidogrel combined with rivaroxaban group is lower and the curative effect is not inferior to that of triple antithrombotic regimen. Whether rivaroxaban can replace aspirin for coronary heart disease complicated with gastrointestinal diseases has no research evidence and no relevant guidelines.
Methods:Patients who have been selected will be randomized to the clopidogrel combined with rivaroxaban arm versus the clopidogrel combined with aspirin arm. Patients selected in the clopidogrel combined with rivaroxaban arm will receive clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily. Patients selected in the clopidogrel combined with aspirin arm will receive clopidogrel 75 mg once daily and aspirin 100 mg once daily. The therapy will last for at least six months in the both arms. The primary endpoints will be evaluated at six-months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: clopidogrel combined with rivaroxaban armPatients selected in the clopidogrel combined with rivaroxaban arm will receive clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrel combined with rivaroxaban armAlso: clopidogrel combined with rivaroxabanPatients 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 | Drug | clopidogrel combined with rivaroxaban arm |
Primary outcome
Occurrence of moderate and serve bleeding events which is identified by Bleeding Academic Research Consortium (BARC)
Time frame: 6 months
Bleeding Academic Research Consortium (BARC)
1 secondary outcome
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel combined with rivaroxaban arm in people with Rivaroxaban, run by Shenyang Northern Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of moderate and serve bleeding events which is identified by Bleeding Academic Research Consortium (BARC) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.