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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months following the cardiac operation
Awards & highlights
Pivotal Trial
Approved for 20 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial compares two blood thinners, Warfarin and Rivaroxaban, in patients who develop an irregular heartbeat after heart surgery. Warfarin works by blocking Vitamin K to prevent clotting, while Rivaroxaban blocks a specific protein needed for clotting. The study aims to determine which drug is safer and more cost-effective.
Eligible Conditions
- Atrial Fibrillation
- Hemorrhage
- Stroke
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months following the cardiac operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months following the cardiac operation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Postoperative Length of Stay
Secondary study objectives
Average score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2)
Cerebrovascular accident (CVA)
Deep venous thrombosis (DVT) and/or Pulmonary Embolism (PE)
+10 moreSide effects data
From 2020 Phase 3 trial • 179 Patients • NCT021645782%
Hypertensive crisis
1%
Diverticulitis
1%
Chest pain
1%
Bile duct stone
1%
Cerebrovascular accident
1%
Nausea
1%
Foot fracture
1%
Erysipelas
1%
Vomiting
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aspirin
Rivaroxaban
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
3,012 Previous Clinical Trials
13,309,171 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking medication to prevent blood clots after surgery that cannot be stopped when another blood thinning medication is started.Your kidneys are not working well (GFR < 30 ml/min), you have abnormal blood clotting (baseline INR > 1.7), you have a blockage in your digestive system that makes it hard to take oral medication, or you have known problems with your body's ability to clot blood.You have a type of irregular heart rhythm called paroxysmal atrial fibrillation before heart surgery.You have experienced bleeding after a surgery before starting the study drug.You currently need to take medication to prevent blood clots, like for a previous blood clot or heart valve issue.You have a moderate to severe narrowing of your mitral valve that hasn't been fixed with surgery.You are already allergic to the medications used in the study.You have had heart surgeries like bypass grafting, valve repairs, or non-mechanical valve replacements.You have had a stroke within the past month before surgery or after surgery but before starting the study medication.
Research Study Groups:
This trial has the following groups:- Group 1: Warfarin
- Group 2: Rivaroxaban
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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