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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03605433
Other study ID # SCOOP
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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