Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets (SCOOP)

Centro Hospitalar e Universitário de Coimbra, E.P.E.

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease; Saphenous Vein Graft Patency

Treatments: Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT03605433

SCOOP

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Oral Anticoagulation+Antiplatelet

Experimental group

Description:

Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.

Treatment:

Drug: Rivaroxaban

Oral Anticoagulation

Experimental group

Description:

Rivaroxaban 20 mg once daily

Treatment:

Drug: Rivaroxaban

Antiplatet

Active Comparator group

Description:

Aspirin 100 mg once daily

Treatment:

Drug: Rivaroxaban