Atrial FibrillationPhase 4NCT04023630
DUAL Antithrombotic Therapy in Patients With AF and ACS
A Phase 4 study testing Rivaroxaban 15 MG Oral Tablet, Clopidogrel 75 Mg Oral Tablet and Ticagrelor 90 MG Oral Tablet in people with Atrial Fibrillation and Acute Coronary Syndromes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Atrial Fibrillation, Acute Coronary Syndromes
- What is being tested?
- Rivaroxaban 15 MG Oral Tablet, Clopidogrel 75 Mg Oral Tablet and Ticagrelor 90 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 30 Sep 2021
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome
- Planned use of antiplatelet agents for at least 12 months
- Males and Females ≥ 18 years of age
- Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
Who cannot join
- Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
- Patients with a history of intracranial hemorrhage
- Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
- Patients with known ongoing bleeding and patients with known coagulopathies
- Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists
Show all 9Show fewer
- Have a history of stroke or Transient Ischemic Attack (TIA)
- Have known significant liver disease or liver function test (LFT) abnormalities
- Have any severe condition that would limit life expectancy to less than 12 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome
The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
Read the detailed description
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
- Conditions
- Atrial Fibrillation, Acute Coronary Syndromes
- Being tested
- Rivaroxaban 15 MG Oral Tablet, Clopidogrel 75 Mg Oral Tablet, Ticagrelor 90 MG Oral Tablet
- Medical subject headings
- Atrial Fibrillation, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 15 MG Oral TabletDrug
Also called Xarelto
One 15 mg tablet once daily for up to twelve months
Clopidogrel 75 Mg Oral TabletDrug
Also called P2Y12 antagonists
One 75 mg tablet once daily for up to twelve months
Ticagrelor 90 MG Oral TabletDrug
Also called P2Y12 antagonists
One 90 mg tablet twice daily for up to twelve months
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban plus ticagrelor | Experimental | rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months Receives: Drug: Rivaroxaban 15 MG Oral Tablet; Drug: Ticagrelor 90 MG Oral Tablet |
| rivaroxaban plus clopidogrel | Active comparator | rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months Receives: Drug: Rivaroxaban 15 MG Oral Tablet; Drug: Clopidogrel 75 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite endpoints of death and ischemic events
The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )
Measured: one year
Secondary outcomes (1)
Clinically significant bleeding
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian'an Wang,MD,PhD, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Jun Jiang, PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023630
- Sponsor's protocol ID
- SAHZJU CT013
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 17 Jul 2019
- 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 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04023630
- Acronym / sponsor ID
- SAHZJU CT013
- Conditions
- Atrial Fibrillation, Acute Coronary Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 17 Jul 2019 (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 study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
Detailed description
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban plus ticagrelor | Experimental | Drug: Rivaroxaban 15 MG Oral Tablet, Drug: Ticagrelor 90 MG Oral Tabletrivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months |
| rivaroxaban plus clopidogrel | Active comparator | Drug: Rivaroxaban 15 MG Oral Tablet, Drug: Clopidogrel 75 Mg Oral Tabletrivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome
- Planned use of antiplatelet agents for at least 12 months
- Males and Females ≥ 18 years of age
- Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
Key exclusion criteria (9 listed)
- Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
- Patients with a history of intracranial hemorrhage
- Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
- Patients with known ongoing bleeding and patients with known coagulopathies
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 |
|---|---|---|
| Rivaroxaban 15 MG Oral TabletAlso: XareltoOne 15 mg tablet once daily for up to twelve months | Drug | rivaroxaban plus clopidogrel, rivaroxaban plus ticagrelor |
| Clopidogrel 75 Mg Oral TabletAlso: P2Y12 antagonistsOne 75 mg tablet once daily for up to twelve months | Drug | rivaroxaban plus clopidogrel |
| Ticagrelor 90 MG Oral TabletAlso: P2Y12 antagonistsOne 90 mg tablet twice daily for up to twelve months | Drug | rivaroxaban plus ticagrelor |
Primary outcome
The composite endpoints of death and ischemic events
Time frame: one year
The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )
1 secondary outcome
Clinically significant bleeding
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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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.
Jun Jiang, PhD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 15 MG Oral Tablet, Clopidogrel 75 Mg Oral Tablet and Ticagrelor 90 MG Oral Tablet in people with Atrial Fibrillation and Acute Coronary Syndromes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 9 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 17 Jul 2019. 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?
Contact Jun Jiang, PhD (13588706891, hu888po@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite endpoints of death and ischemic events (time frame: one year). 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 17 Jul 2019.