Coronary Artery DiseasePhase 3SCOOPNCT03605433
Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets
A Phase 3 study testing Rivaroxaban in people with Coronary Artery Disease and Saphenous Vein Graft Patency, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial summary
The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Saphenous Vein Graft Patency
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2018to 31 Dec 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to coronary artery bypass graft and at least one saphenous vein graft
Who cannot join
- Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
- Stroke within 1 month or any history of hemorrhagic or lacunar stroke
- Estimated glomerular filtration rate (eGFR)<15 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies
The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.
- Being tested
- Rivaroxaban
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Oral Anticoagulation+Antiplatelet | Experimental | Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. Receives: Drug: Rivaroxaban |
| Oral Anticoagulation | Experimental | Rivaroxaban 20 mg once daily Receives: Drug: Rivaroxaban |
| Antiplatet | Active comparator | Aspirin 100 mg once daily Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
Measured: 5 years
Graft Patency
Time from randomization to the first occurence of saphenous graft oclusion
Measured: 5 years
Major Bleeding
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
Measured: 5 years
Secondary outcomes (2)
MACE, cardiovascular death
Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia
Measured: 5 years
All-cause mortality
Time from randomization to first occurrence of all-cause mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Dec 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís Paiva, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605433
- Sponsor's protocol ID
- SCOOP
- Acronym
- SCOOP
- Status last verified
- Jul 2018
- First submitted
- 22 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies
- ClinicalTrials.gov ID
- NCT03605433
- Acronym / sponsor ID
- SCOOP / SCOOP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Jul 2018 (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 primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Anticoagulation+Antiplatelet | Experimental | Drug: RivaroxabanRivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. |
| Oral Anticoagulation | Experimental | Drug: RivaroxabanRivaroxaban 20 mg once daily |
| Antiplatet | Active comparator | Drug: RivaroxabanAspirin 100 mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred to coronary artery bypass graft and at least one saphenous vein graft
Key exclusion criteria (3 listed)
- Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
- Stroke within 1 month or any history of hemorrhagic or lacunar stroke
- Estimated glomerular filtration rate (eGFR)<15 mL/min
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 |
|---|---|---|
| RivaroxabanRivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation | Drug | Antiplatet, Oral Anticoagulation, Oral Anticoagulation+Antiplatelet |
Primary outcome
MACE
Time frame: 5 years
Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
Graft Patency
Time frame: 5 years
Time from randomization to the first occurence of saphenous graft oclusion
Major Bleeding
Time frame: 5 years
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
2 secondary outcomes
MACE, cardiovascular death
Time frame: 5 years
All-cause mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban in people with Coronary Artery Disease and Saphenous Vein Graft Patency, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
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 3 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 30 Jul 2018. 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 Portugal. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Luis Paiva, MD (+351917952197, luisvpaiva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 5 years). The study lists 3 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 30 Jul 2018.