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Novel Oral Anticoagulant

Rivaroxaban for Atrial Fibrillation (NEW-AF Trial)

Phase 3
Waitlist Available
Led By Thoralf M Sundt, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least one of the following procedures: coronary artery bypass grafting, aortic valve repair, mitral valve repair, non-mechanical aortic valve replacement, any combination of these procedures
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months following the cardiac operation
Awards & highlights

NEW-AF Trial 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
  • Bleeding
  • Stroke

NEW-AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had heart surgeries like bypass grafting, valve repairs, or non-mechanical valve replacements.

NEW-AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months following the cardiac operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months following the cardiac operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Length of Stay
Secondary outcome measures
Average score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2)
Cerebrovascular accident (CVA)
Deep venous thrombosis (DVT) and/or Pulmonary Embolism (PE)
+10 more

Side effects data

From 2020 Phase 3 trial • 179 Patients • NCT02164578
1%
Hypertension
1%
Ovarian cyst
1%
Osteoarthritis
1%
Gastrointestinal hemorrhage
1%
Escherichia sepsis
1%
Joint arthroplasty
1%
Leiomyoma
1%
Syncope
1%
Asthma
1%
Hysterectomy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rivaroxaban
Aspirin

NEW-AF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RivaroxabanExperimental Treatment1 Intervention
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade) Dosage form: Per Os (Oral) Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal. Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Group II: WarfarinActive Control1 Intervention
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors Dosage form: Per Os (Oral) Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen. Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,868 Total Patients Enrolled
15 Trials studying Atrial Fibrillation
65,583 Patients Enrolled for Atrial Fibrillation
Thoralf M Sundt, MDPrincipal InvestigatorMassachusetts General Hospital
Asishana A Osho, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
484 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
484 Patients Enrolled for Atrial Fibrillation

Media Library

Rivaroxaban (Novel Oral Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03702582 — Phase 3
Atrial Fibrillation Research Study Groups: Warfarin, Rivaroxaban
Atrial Fibrillation Clinical Trial 2023: Rivaroxaban Highlights & Side Effects. Trial Name: NCT03702582 — Phase 3
Rivaroxaban (Novel Oral Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03702582 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have volunteered to participate in this research project?

"That is correct, the online information shows that the trial is currently looking for volunteers. The 300 participants will be recruited from a single site, and the trial was originally posted on April 30th, 2019 with the most recent update being on August 31st, 2021."

Answered by AI

Did the FDA sign off on Rivaroxaban?

"There is some evidence for rivaroxaban's efficacy and several rounds of data backing its safety, so it was given a score of 3."

Answered by AI

Are there other studies that have looked at Rivaroxaban's effects?

"Presently, there are 76 independent clinical trials being conducted for Rivaroxaban. 30 of those trials have advanced to Phase 3. The majority of research facilities are based in Montreal, Quebec; however, there are 1065 total locations running Rivaroxaban trials."

Answered by AI

Are patients still being actively recruited for this trial?

"That is correct, the information on clinicaltrials.gov currently indicates that this study is looking for participants. This study was originally posted on April 30th, 2019 and was last updated on August 31st, 2021. The study is searching for 300 patients from 1 location."

Answered by AI

For what purpose is Rivaroxaban most often prescribed?

"Rivaroxaban is most commonly used to treat patients that have had a cerebrovascular accident. That being said, it can also be used as a preventative measure for people with atrial fibrillation or those that have had a myocardial infarction."

Answered by AI
Recent research and studies
~17 spots leftby Mar 2025