Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets
SCOOP
Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 coronary-artery-disease
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 30, 2018
July 1, 2018
1.1 years
July 22, 2018
July 22, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
MACE
Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
5 years
Graft Patency
Time from randomization to the first occurence of saphenous graft oclusion
5 years
Major Bleeding
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
5 years
Secondary Outcomes (2)
MACE, cardiovascular death
5 years
All-cause mortality
5 years
Study Arms (3)
Oral Anticoagulation+Antiplatelet
EXPERIMENTALRivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
Oral Anticoagulation
EXPERIMENTALRivaroxaban 20 mg once daily
Antiplatet
ACTIVE COMPARATORAspirin 100 mg once daily
Interventions
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
Eligibility Criteria
You may qualify if:
- Patients referred to coronary artery bypass graft and at least one saphenous vein graft
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Luis Paiva
Study Record Dates
First Submitted
July 22, 2018
First Posted
July 30, 2018
Study Start
December 1, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
July 30, 2018
Record last verified: 2018-07