Rivaroxaban Post Coronary Bypass Surgery

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT06019741

Collaborator

(none)

234

Enrollment

Location

Arms

17.5

Actual Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post Coronary Bypass Surgery Patients	Drug: Rivaroxaban and aspirin 80 Drug: Aspirin 80	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized double blind of placebo and intervention grouprandomized double blind of placebo and intervention group

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

simple randomization

Primary Purpose:

Treatment

Official Title:

Rivaroxaban and Aspirin Versus Aspirin Alone in Preventing Atherothrombotic Events in Patients Following Coronary Artery Bypass Graft Surgery

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

Jul 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aspirin and rivaroxaban post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily	Drug: Rivaroxaban and aspirin 80 rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery
Active Comparator: aspirin post coronary bypass patients, received aspirin 80 mg	Drug: Aspirin 80 aspirin 80 mg orally post coronary bypass surgery

Arm

Intervention/Treatment

Experimental: aspirin and rivaroxaban

post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily

Drug: Rivaroxaban and aspirin 80

rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery

Active Comparator: aspirin

post coronary bypass patients, received aspirin 80 mg

Drug: Aspirin 80

aspirin 80 mg orally post coronary bypass surgery

Outcome Measures

Primary Outcome Measures

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

functional capacity [1 year]
functional capacity assessed by exercise tolerance test, based on METS, duration of toleration of exercise

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 87 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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.