Status:

COMPLETED

Rivaroxaban Post Coronary Bypass Surgery

Lead Sponsor:

Shiraz University of Medical Sciences

Conditions:

Post Coronary Bypass Surgery Patients

Eligibility:

All Genders

45-87 years

Phase:

PHASE4

Brief Summary

Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low dose rivaroxaban

Detailed Description

This study is a 1-year randomized, double-blind placebo-controlled trial to evaluate the effects of adding rivaroxaban to the treatment of patients after coronary bypass surgery. All patients referred...

Eligibility Criteria

Inclusion

  • Patients older than 18 undergoing primary isolated coronary bypass surgery, with or without cardiopulmonary bypass

Exclusion

  • Other cardiac surgeries except for coronary bypass surgery
  • Left ventricular ejection fraction \< 30 %
  • Liver disease
  • Clopidogrel or aspirin intake within 7 days of operation
  • Need for perioperative warfarin
  • Active gastroduodenal ulcer or post-operative gastrointestinal bleeding
  • Profuse post-operative pleural effusion (drainage \>200 ml/h for 2 h or more
  • Postoperative low cardiac output syndrome or requirement for high levels of hemodynamic support (more than 2 inotropes for more than 24 h and/or intra-aortic balloon pump)
  • Clinical instability, such as perioperative myocardial infarction or malignant tumor.

Key Trial Info

Start Date :

February 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 20 2022

Estimated Enrollment :

234 Patients enrolled

Trial Details

Trial ID

NCT06019741

Start Date

February 1 2021

End Date

July 20 2022

Last Update

September 6 2023

Active Locations (1)

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Professor Kojuri Cardiology Clinic

Shiraz, Fars, Iran, 55318