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Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

NCT03605433 — Phase 3, Unknown, 100 participants, Unidade Local de Saúde de Coimbra, EPE
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Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies

RegistryNCT03605433, acronym SCOOP
StatusUnknown
PhasePhase 3
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment100 (Estimated)
SponsorUnidade Local de Saúde de Coimbra, EPE (Other)
ConditionsCoronary Artery Disease, Saphenous Vein Graft Patency
InterventionsRivaroxaban (Drug)
Datesstart 2018-12-01 (estimated), primary completion 2019-12-31 (estimated), completion 2020-12-31 (estimated), first posted 2018-07-30, last updated 2018-07-30
Locations1 site in Portugal

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Oral Anticoagulation+AntiplateletExperimentalDrug: RivaroxabanRivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.
Oral AnticoagulationExperimentalDrug: RivaroxabanRivaroxaban 20 mg once daily
AntiplatetActive comparatorDrug: RivaroxabanAspirin 100 mg once daily
  • Rivaroxaban (Drug): Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Centro Hospitalar e Universitário de CoimbraCoimbraPortugal

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