Post Coronary Bypass Surgery PatientsPhase 4NCT06019741
Rivaroxaban Post Coronary Bypass Surgery
A Phase 4 study testing Rivaroxaban and aspirin 80 and Aspirin 80 in people with Post Coronary Bypass Surgery Patients, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low dose rivaroxaban Read more about this study
- Who is it for?
- Ages 45 to 87 years
- Conditions the study is for
- Post Coronary Bypass Surgery Patients
- What is being tested?
- Rivaroxaban and aspirin 80 and Aspirin 80
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2021to 20 Jul 2022
- 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 45 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 undergoing primary isolated coronary bypass surgery, with or without cardiopulmonary bypass
Who cannot join
- Other cardiac surgeries except for coronary bypass surgery
- Left ventricular ejection fraction < 30 %
- Liver disease
- Clopidogrel or aspirin intake within 7 days of operation
- Need for perioperative warfarin
- Active gastroduodenal ulcer or post-operative gastrointestinal bleeding
Show all 9Show fewer
- Profuse post-operative pleural effusion (drainage >200 ml/h for 2 h or more
- Postoperative low cardiac output syndrome or requirement for high levels of hemodynamic support (more than 2 inotropes for more than 24 h and/or intra-aortic balloon pump)
- Clinical instability, such as perioperative myocardial infarction or malignant tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rivaroxaban and Aspirin Versus Aspirin Alone in Preventing Atherothrombotic Events in Patients Following Coronary Artery Bypass Graft Surgery
Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low dose rivaroxaban
Read the detailed description
This study is a 1-year randomized, double-blind placebo-controlled trial to evaluate the effects of adding rivaroxaban to the treatment of patients after coronary bypass surgery. All patients referred for either off-pump or on-pump coronary bypass surgery to 3 academic hospitals in Shiraz, Iran were screened according to inclusion criteria. Clinicians at these sites were informed of this study and asked to refer patients after coronary bypass surgery.
A total of 414 patients were initially included in the study, but 171 of them were excluded based on the exclusion criteria (Figure 1). The remaining 243 patients were then randomly divided into two groups: group 1, receiving aspirin 80 mg daily plus placebo; group 2, receiving aspirin 80 mg daily plus rivaroxaban 2.5 mg twice daily.
Clinical outcomes were assessed at the end of first year post-operation. Subjects will undergo a complete history and physical examination and the study variables were assessed. Patients were followed every 2 weeks for any occurrence at these visits, patients' compliance was assessed, standard medication was adjusted as appropriate, and all interventions, outcome events, and adverse events were recorded. The patients were followed for the occurrence of major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist); and 3) cerebrovascular accidents. Occurrence of major bleeding and chest pain, and functional capacity exercise (assessed with exercise tolerance test) were also evaluated. Additional variables that will be collected at baseline include demographic and clinical characteristics of patients as follows: sex (male, female), age (mean (SD)), hypertension (yes/no), and diabetes mellitus (yes/no).
To document any unfavorable occurrences, the patients were questioned via telephone monthly about any potential side effects.
- Conditions
- Post Coronary Bypass Surgery Patients
- Being tested
- Rivaroxaban and aspirin 80, Aspirin 80
- Keywords
- coronary bypass surgery, aspirin, rivaroxaban, MACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban and aspirin 80Drug
rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery
Aspirin 80Drug
aspirin 80 mg orally post coronary bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| aspirin and rivaroxaban | Experimental | post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily Receives: Drug: Rivaroxaban and aspirin 80 |
| aspirin | Active comparator | post coronary bypass patients, received aspirin 80 mg Receives: Drug: Aspirin 80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist) ,and 3) cerebrovascular accidents
Measured: 1 year
bleeding
all types of reported bleeding, major or minor
Measured: 1 year
Secondary outcomes (1)
functional capacity
functional capacity assessed by exercise tolerance test, based on METS, duration of toleration of exercise
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Feb 2021
- Primary completion1 May 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Coronary Bypass Surgery PatientsStudies 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
- Model description
- randomized double blind of placebo and intervention group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019741
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1401.411
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available in professor kojuri registry, and will be available upon rational request
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban and Aspirin Versus Aspirin Alone in Preventing Atherothrombotic Events in Patients Following Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06019741
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1401.411
- Conditions
- Post Coronary Bypass Surgery Patients
- Keywords
- coronary bypass surgery, aspirin, rivaroxaban, MACE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 31 Aug 2023 (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.
Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low dose rivaroxaban
Detailed description
This study is a 1-year randomized, double-blind placebo-controlled trial to evaluate the effects of adding rivaroxaban to the treatment of patients after coronary bypass surgery. All patients referred for either off-pump or on-pump coronary bypass surgery to 3 academic hospitals in Shiraz, Iran were screened according to inclusion criteria. Clinicians at these sites were informed of this study and asked to refer patients after coronary bypass surgery.
A total of 414 patients were initially included in the study, but 171 of them were excluded based on the exclusion criteria (Figure 1). The remaining 243 patients were then randomly divided into two groups: group 1, receiving aspirin 80 mg daily plus placebo; group 2, receiving aspirin 80 mg daily plus rivaroxaban 2.5 mg twice daily.
Clinical outcomes were assessed at the end of first year post-operation. Subjects will undergo a complete history and physical examination and the study variables were assessed. Patients were followed every 2 weeks for any occurrence at these visits, patients' compliance was assessed, standard medication was adjusted as appropriate, and all interventions, outcome events, and adverse events were recorded. The patients were followed for the occurrence of major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist); and 3) cerebrovascular accidents. Occurrence of major bleeding and chest pain, and functional capacity exercise (assessed with exercise tolerance test) were also evaluated. Additional variables that will be collected at baseline include demographic and clinical characteristics of patients as follows: sex (male, female), age (mean (SD)), hypertension (yes/no), and diabetes mellitus (yes/no).
To document any unfavorable occurrences, the patients were questioned via telephone monthly about any potential side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind of placebo and intervention group
| Arm | Type | Receives |
|---|---|---|
| aspirin and rivaroxaban | Experimental | Drug: Rivaroxaban and aspirin 80post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily |
| aspirin | Active comparator | Drug: Aspirin 80post coronary bypass patients, received aspirin 80 mg |
Who may qualify
- Ages
- 45 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 undergoing primary isolated coronary bypass surgery, with or without cardiopulmonary bypass
Key exclusion criteria (9 listed)
- Other cardiac surgeries except for coronary bypass surgery
- Left ventricular ejection fraction < 30 %
- Liver disease
- Clopidogrel or aspirin intake within 7 days of operation
- Need for perioperative warfarin
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 and aspirin 80rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery | Drug | aspirin and rivaroxaban |
| Aspirin 80aspirin 80 mg orally post coronary bypass surgery | Drug | aspirin |
Primary outcome
MACE
Time frame: 1 year
Major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist) ,and 3) cerebrovascular accidents
bleeding
Time frame: 1 year
all types of reported bleeding, major or minor
1 secondary outcome
functional capacity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No. Data is available in professor kojuri registry, and will be available upon rational request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban and aspirin 80 and Aspirin 80 in people with Post Coronary Bypass Surgery Patients, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 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: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MACE (time frame: 1 year). The study lists 2 primary outcomes in all. 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 6 Sep 2023.