- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03605433
Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets (SCOOP)
July 22, 2018 updated by: Luís Paiva, Centro Hospitalar e Universitário de Coimbra, E.P.E.
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luis Paiva, MD
- Phone Number: +351917952197
- Email: luisvpaiva@gmail.com
Study Locations
-
-
-
Coimbra, Portugal
- Centro Hospitalar e Universitário de Coimbra
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients referred to coronary artery bypass graft and at least one saphenous vein graft
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oral Anticoagulation+Antiplatelet
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
|
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
|
EXPERIMENTAL: Oral Anticoagulation
Rivaroxaban 20 mg once daily
|
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
|
ACTIVE_COMPARATOR: Antiplatet
Aspirin 100 mg once daily
|
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE
Time Frame: 5 years
|
Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
|
5 years
|
Graft Patency
Time Frame: 5 years
|
Time from randomization to the first occurence of saphenous graft oclusion
|
5 years
|
Major Bleeding
Time Frame: 5 years
|
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE, cardiovascular death
Time Frame: 5 years
|
Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia
|
5 years
|
All-cause mortality
Time Frame: 5 years
|
Time from randomization to first occurrence of all-cause mortality
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2018
Primary Completion (ANTICIPATED)
December 31, 2019
Study Completion (ANTICIPATED)
December 31, 2020
Study Registration Dates
First Submitted
July 22, 2018
First Submitted That Met QC Criteria
July 22, 2018
First Posted (ACTUAL)
July 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 22, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
Other Study ID Numbers
- SCOOP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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