Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

Coronary Artery Disease Clinical Trial

— SCOOP  

Official title:

Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03605433
• Other study ID #: SCOOP
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2018
• Source: Centro Hospitalar e Universitário de Coimbra, E.P.E.
• Contact: Luis Paiva, MD
• Phone: +351917952197
• Email: luisvpaiva[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Saphenous Vein Graft Patency

Intervention

Drug:
• Rivaroxaban
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation

Locations

Country	Name	City	State
Portugal	Centro Hospitalar e Universitário de Coimbra	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar e Universitário de Coimbra, E.P.E.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death	5 years
Primary	Graft Patency	Time from randomization to the first occurence of saphenous graft oclusion	5 years
Primary	Major Bleeding	Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)	5 years
Secondary	MACE, cardiovascular death	Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia	5 years
Secondary	All-cause mortality	Time from randomization to first occurrence of all-cause mortality	5 years