Rivaroxaban Post Coronary Bypass Surgery

Phase 4

Completed

• Conditions: Post Coronary Bypass Surgery Patients
• Interventions: Drug: Aspirin 80; Drug: Rivaroxaban and aspirin 80

• Registration Number: NCT06019741
• Lead Sponsor: Shiraz University of Medical Sciences

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 for either off-pump or on-pump coronary bypass surgery to 3 academic hospitals in Shiraz, Iran were screened according to inclusion criteria. Clinicians at these sites were informed of this study and asked to refer patients after coronary bypass surgery.

A total of 414 patients were initially included in the study, but 171 of them were excluded based on the exclusion criteria (Figure 1). The remaining 243 patients were then randomly divided into two groups: group 1, receiving aspirin 80 mg daily plus placebo; group 2, receiving aspirin 80 mg daily plus rivaroxaban 2.5 mg twice daily.

Clinical outcomes were assessed at the end of first year post-operation. Subjects will undergo a complete history and physical examination and the study variables were assessed. Patients were followed every 2 weeks for any occurrence at these visits, patients' compliance was assessed, standard medication was adjusted as appropriate, and all interventions, outcome events, and adverse events were recorded. The patients were followed for the occurrence of major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist); and 3) cerebrovascular accidents. Occurrence of major bleeding and chest pain, and functional capacity exercise (assessed with exercise tolerance test) were also evaluated. Additional variables that will be collected at baseline include demographic and clinical characteristics of patients as follows: sex (male, female), age (mean (SD)), hypertension (yes/no), and diabetes mellitus (yes/no).

To document any unfavorable occurrences, the patients were questioned via telephone monthly about any potential side effects.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-07-20
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin	Aspirin 80	post coronary bypass patients, received aspirin 80 mg
aspirin and rivaroxaban	Rivaroxaban and aspirin 80	post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily

Primary Outcome Measures

Name	Time	Method
MACE	1 year	Major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist) ,and 3) cerebrovascular accidents
bleeding	1 year	all types of reported bleeding, major or minor

Secondary Outcome Measures

Name	Time	Method
functional capacity	1 year	functional capacity assessed by exercise tolerance test, based on METS, duration of toleration of exercise

Trial Locations

Locations (1)

Professor Kojuri Cardiology Clinic; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of