Rivaroxaban Post Coronary Bypass Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Post Coronary Bypass Surgery Patients
• Intervention / Treatment: Drug: Rivaroxaban and aspirin 80; Drug: Aspirin 80

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 Type: Interventional
• Enrollment (Actual): 234
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of, 55318
      • professor Kojuri cardiology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	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	1 year
bleeding	all types of reported bleeding, major or minor	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional capacity	functional capacity assessed by exercise tolerance test, based on METS, duration of toleration of exercise	1 year

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: aspirin; rivaroxaban; MACE; coronary bypass surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Rivaroxaban
• Other Study ID Numbers: IR.SUMS.MED.REC.1401.411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data is available in professor kojuri registry, and will be available upon rational request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No