Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

Phase 3

• Conditions: Coronary Artery Disease; Saphenous Vein Graft Patency
• Interventions: Drug: Rivaroxaban

• Registration Number: NCT03605433
• Lead Sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-22
• Last Update Submitted: 2018-07-22
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30
• Study Start: 2018-12-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Anticoagulation	Rivaroxaban	Rivaroxaban 20 mg once daily
Oral Anticoagulation+Antiplatelet	Rivaroxaban	Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
Antiplatet	Rivaroxaban	Aspirin 100 mg once daily

Primary Outcome Measures

Name	Time	Method
MACE	5 years	Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death
Graft Patency	5 years	Time from randomization to the first occurence of saphenous graft oclusion
Major Bleeding	5 years	Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)

Secondary Outcome Measures

Name	Time	Method
MACE, cardiovascular death	5 years	Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia
All-cause mortality	5 years	Time from randomization to first occurrence of all-cause mortality

Trial Locations

Locations (1)

Centro Hospitalar e Universitário de Coimbra; 🇵🇹 Coimbra, Portugal