Back to resultsSurgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets (SCOOP)
Primary Purpose
Coronary Artery Disease, Saphenous Vein Graft Patency
Status
Unknown status
Phase
Phase 3
Locations
Portugal
Study Type
Interventional
Intervention
Rivaroxaban
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Centro Hospitalar e Universitário de Coimbra
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Oral Anticoagulation+Antiplatelet
Oral Anticoagulation
Antiplatet
Arm Description
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
Rivaroxaban 20 mg once daily
Aspirin 100 mg once daily
Outcomes
Primary Outcome Measures
MACE
Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
Graft Patency
Time from randomization to the first occurence of saphenous graft oclusion
Major Bleeding
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
Secondary Outcome Measures
MACE, cardiovascular death
Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia
All-cause mortality
Time from randomization to first occurrence of all-cause mortality
Full Information
NCT ID
NCT03605433
First Posted
July 22, 2018
Last Updated
July 22, 2018
Sponsor
Centro Hospitalar e Universitário de Coimbra, E.P.E.
1. Study Identification
Unique Protocol Identification Number
NCT03605433
Brief Title
Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets
Acronym
SCOOP
Official Title
Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar e Universitário de Coimbra, E.P.E.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Saphenous Vein Graft Patency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Anticoagulation+Antiplatelet
Arm Type
Experimental
Arm Description
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
Arm Title
Oral Anticoagulation
Arm Type
Experimental
Arm Description
Rivaroxaban 20 mg once daily
Arm Title
Antiplatet
Arm Type
Active Comparator
Arm Description
Aspirin 100 mg once daily
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
Primary Outcome Measure Information:
Title
MACE
Description
Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
Time Frame
5 years
Title
Graft Patency
Description
Time from randomization to the first occurence of saphenous graft oclusion
Time Frame
5 years
Title
Major Bleeding
Description
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
MACE, cardiovascular death
Description
Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia
Time Frame
5 years
Title
All-cause mortality
Description
Time from randomization to first occurrence of all-cause mortality
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Paiva, MD
Phone
+351917952197
Email
luisvpaiva@gmail.com
Facility Information:
Facility Name
Centro Hospitalar e Universitário de Coimbra
City
Coimbra
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets
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