Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets (SCOOP)

July 22, 2018 updated by: Luís Paiva, Centro Hospitalar e Universitário de Coimbra, E.P.E.

Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal
        • Centro Hospitalar e Universitario de Coimbra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oral Anticoagulation+Antiplatelet
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
Drug: Rivaroxaban
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
EXPERIMENTAL: Oral Anticoagulation
Rivaroxaban 20 mg once daily
Drug: Rivaroxaban
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
ACTIVE_COMPARATOR: Antiplatet
Aspirin 100 mg once daily
Drug: Rivaroxaban
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

July 22, 2018

First Submitted That Met QC Criteria

July 22, 2018

First Posted (ACTUAL)

July 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 22, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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