Rivaroxaban for Atrial Fibrillation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Atrial Fibrillation+2 MoreRivaroxaban - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares the safety and financial benefits of two different drugs to prevent blood clots in people with a heart condition.

Eligible Conditions
  • Atrial Fibrillation
  • Stroke
  • Bleeding

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Up to 6 months following the cardiac operation

Day 30
Average score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2)
Cerebrovascular accident (CVA)
Deep venous thrombosis (DVT) and/or Pulmonary Embolism (PE)
Hemorrhage
Hospital Readmission
Minor Bleeding
Number of Transfusions
Other systemic embolism
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Rate of Mortality
Rate of ongoing atrial fibrillation
Rates of adverse clinical outcomes
Therapy related costs of anticoagulation
Month 6
Postoperative Length of Stay

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Rivaroxaban
24%Others
4%Constipation
4%Hypertension
3%Dizziness
3%Nausea
2%Anaemia
2%Musculoskeletal pain
1%Large intestine polyp
1%International normalised ratio increased
1%Cerebral infarction
1%Depression
1%Hypotension
1%Atrial fibrillation
1%Gastrooesophageal reflux disease
1%Stroke in evolution
1%Insomnia
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT02042534) in the Rivaroxaban ARM group. Side effects include: Others with 24%, Constipation with 4%, Hypertension with 4%, Dizziness with 3%, Nausea with 3%.

Trial Design

2 Treatment Groups

Warfarin
1 of 2
Rivaroxaban
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Rivaroxaban · No Placebo Group · Phase 3

Rivaroxaban
Drug
Experimental Group · 1 Intervention: Rivaroxaban · Intervention Types: Drug
Warfarin
Drug
ActiveComparator Group · 1 Intervention: Warfarin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months following the cardiac operation

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,852,860 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
65,106 Patients Enrolled for Atrial Fibrillation
Thoralf M Sundt, MDPrincipal InvestigatorMassachusetts General Hospital
Asishana A Osho, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
242 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
242 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
References