Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

NCT ID: NCT03605433

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease Saphenous Vein Graft Patency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Anticoagulation+Antiplatelet

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

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation

Oral Anticoagulation

Rivaroxaban 20 mg once daily

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation

Antiplatet

Aspirin 100 mg once daily

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation

Interventions

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Rivaroxaban

Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unidade Local de Saúde de Coimbra, EPE

OTHER

Sponsor Role lead

Responsible Party

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Luís Paiva

Luis Paiva

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro Hospitalar e Universitário de Coimbra

Coimbra, , Portugal

Site Status

Countries

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Portugal

Central Contacts

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Luis Paiva, MD

Role: CONTACT

+351917952197

Other Identifiers

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SCOOP

Identifier Type: -

Identifier Source: org_study_id

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