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Rivaroxaban Post Coronary Bypass Surgery

S

Shiraz University of Medical Sciences

Status and phase

Completed
Phase 4

Conditions

Post Coronary Bypass Surgery Patients

Treatments

Drug: Aspirin 80
Drug: Rivaroxaban and aspirin 80

Study type

Interventional

Funder types

Other

Identifiers

NCT06019741
IR.SUMS.MED.REC.1401.411

Details and patient eligibility

About

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

Full 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.

Enrollment

234 patients

Sex

All

Ages

45 to 87 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

234 participants in 2 patient groups

aspirin and rivaroxaban
Experimental group
Description:
post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily
Treatment:
Drug: Rivaroxaban and aspirin 80
aspirin
Active Comparator group
Description:
post coronary bypass patients, received aspirin 80 mg
Treatment:
Drug: Aspirin 80

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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