NCT06019741

Rivaroxaban Post Coronary Bypass Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 45 Years – 87 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Coronary Bypass Surgery Patients

Interventions

Type	Name	Description
DRUG	Rivaroxaban and aspirin 80	rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery
DRUG	Aspirin 80	aspirin 80 mg orally post coronary bypass surgery

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-05-01
• Completion: 2022-07-20
• First posted: 2023-08-31
• Last updated: 2023-09-06

Locations

1 site across 1 country: Iran