Rivaroxaban Post Coronary Bypass Surgery

NCT ID: NCT06019741

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-07-20

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.

Conditions

Post Coronary Bypass Surgery Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

aspirin and rivaroxaban

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

Group Type: EXPERIMENTAL

Rivaroxaban and aspirin 80

Intervention Type: DRUG

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

aspirin

post coronary bypass patients, received aspirin 80 mg

Group Type: ACTIVE_COMPARATOR

Aspirin 80

Intervention Type: DRUG

aspirin 80 mg orally post coronary bypass surgery

Interventions

Rivaroxaban and aspirin 80

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

Intervention Type: DRUG

Aspirin 80

aspirin 80 mg orally post coronary bypass surgery

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 87 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Javad Kojuri

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Professor Kojuri Cardiology Clinic

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

IR.SUMS.MED.REC.1401.411

Identifier Type: -

Identifier Source: org_study_id