Rivaroxaban Post Coronary Bypass Surgery

NCT06019741 | Completed Phase 4 DMC

• 1 other identifier: IR.SUMS.MED.REC.1401.411
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Coronary Bypass Surgery Patients

Keywords

coronary bypass surgery; aspirin; rivaroxaban; MACE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• functional capacity

  1 year

Study Arms (2)

aspirin and rivaroxaban

EXPERIMENTAL

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

Drug: Rivaroxaban and aspirin 80

aspirin

ACTIVE COMPARATOR

post coronary bypass patients, received aspirin 80 mg

Drug: Aspirin 80

Interventions

Rivaroxaban and aspirin 80 DRUG

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

aspirin and rivaroxaban

Aspirin 80 DRUG

aspirin 80 mg orally post coronary bypass surgery

aspirin

Eligibility Criteria

• Age: 45 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Professor Kojuri Cardiology Clinic

Shiraz, Fars, 55318, Iran

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: simple randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: randomized double blind of placebo and intervention group

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: February 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 20, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)