RE-LY trial
E861731
The RE-LY trial was a large, pivotal clinical study that compared the efficacy and safety of the oral anticoagulant dabigatran with warfarin for stroke prevention in patients with atrial fibrillation.
All labels observed (1)
| Label | Occurrences |
|---|---|
| RE-LY trial canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T10401946 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
Target entity: RE-LY trial Context triple: [dabigatran, hasClinicalTrial, RE-LY trial]
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A.
APHINITY trial
The APHINITY trial is a large phase III clinical study that evaluated the addition of pertuzumab (Perjeta) to standard trastuzumab-based adjuvant therapy in patients with HER2-positive early breast cancer.
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B.
CLEOPATRA trial
The CLEOPATRA trial was a pivotal phase III clinical study that demonstrated improved survival by adding pertuzumab (Perjeta) to trastuzumab and docetaxel in patients with HER2-positive metastatic breast cancer.
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C.
ENGAGE (Study 301)
ENGAGE (Study 301) is a large Phase 3 clinical trial designed to evaluate the efficacy and safety of the anti-amyloid monoclonal antibody aducanumab (Aduhelm) in patients with early Alzheimer’s disease.
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D.
EMERGE (Study 302)
EMERGE (Study 302) is a pivotal Phase 3 clinical trial designed to evaluate the efficacy and safety of the Alzheimer’s disease drug aducanumab (Aduhelm) in patients with early-stage Alzheimer’s.
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E.
Jackson Heart Study
The Jackson Heart Study is a large, long-term epidemiological research project focused on understanding cardiovascular disease and its risk factors among African American communities, particularly in Jackson, Mississippi.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
Target entity: RE-LY trial Target entity description: The RE-LY trial was a large, pivotal clinical study that compared the efficacy and safety of the oral anticoagulant dabigatran with warfarin for stroke prevention in patients with atrial fibrillation.
-
A.
APHINITY trial
The APHINITY trial is a large phase III clinical study that evaluated the addition of pertuzumab (Perjeta) to standard trastuzumab-based adjuvant therapy in patients with HER2-positive early breast cancer.
-
B.
CLEOPATRA trial
The CLEOPATRA trial was a pivotal phase III clinical study that demonstrated improved survival by adding pertuzumab (Perjeta) to trastuzumab and docetaxel in patients with HER2-positive metastatic breast cancer.
-
C.
ENGAGE (Study 301)
ENGAGE (Study 301) is a large Phase 3 clinical trial designed to evaluate the efficacy and safety of the anti-amyloid monoclonal antibody aducanumab (Aduhelm) in patients with early Alzheimer’s disease.
-
D.
EMERGE (Study 302)
EMERGE (Study 302) is a pivotal Phase 3 clinical trial designed to evaluate the efficacy and safety of the Alzheimer’s disease drug aducanumab (Aduhelm) in patients with early-stage Alzheimer’s.
-
E.
Jackson Heart Study
The Jackson Heart Study is a large, long-term epidemiological research project focused on understanding cardiovascular disease and its risk factors among African American communities, particularly in Jackson, Mississippi.
- F. None of above. chosen
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
clinical trial
ⓘ
phase III trial ⓘ randomized controlled trial ⓘ |
| acronym | RE-LY NERFINISHED ⓘ |
| anticoagulantMechanismStudied | direct thrombin inhibition ⓘ |
| clinicalQuestion | whether dabigatran can replace warfarin for stroke prevention in atrial fibrillation ⓘ |
| comparatorDrug | warfarin ⓘ |
| comparatorDrugClass | vitamin K antagonist ⓘ |
| controlGroup | dose-adjusted warfarin ⓘ |
| dabigatranDoseArm |
110 mg twice daily
ⓘ
150 mg twice daily ⓘ |
| designFeature |
blinded dabigatran doses
ⓘ
multicenter ⓘ open-label warfarin arm ⓘ prospective ⓘ randomized ⓘ |
| drugClassStudied | direct thrombin inhibitor ⓘ |
| efficacyOutcome |
hemorrhagic stroke
ⓘ
ischemic stroke ⓘ systemic embolism ⓘ |
| enrollmentSize | over 18,000 patients ⓘ |
| fullName | Randomized Evaluation of Long-Term Anticoagulation Therapy NERFINISHED ⓘ |
| geographicScope | international ⓘ |
| impact |
influenced atrial fibrillation stroke prevention guidelines
ⓘ
supported regulatory approval of dabigatran for stroke prevention in atrial fibrillation ⓘ |
| indicationStudied | nonvalvular atrial fibrillation ⓘ |
| interventionDrug | dabigatran etexilate NERFINISHED ⓘ |
| keyFinding |
both dabigatran doses reduced intracranial hemorrhage compared with warfarin
ⓘ
dabigatran 110 mg twice daily had lower major bleeding than warfarin ⓘ dabigatran 110 mg twice daily was noninferior to warfarin for stroke or systemic embolism ⓘ dabigatran 150 mg twice daily increased gastrointestinal bleeding compared with warfarin ⓘ dabigatran 150 mg twice daily reduced stroke or systemic embolism compared with warfarin ⓘ overall mortality was similar or slightly lower with dabigatran compared with warfarin ⓘ |
| patientCondition | increased risk of stroke ⓘ |
| patientPopulation | adult patients ⓘ |
| population | patients with atrial fibrillation at risk of stroke ⓘ |
| primaryEndpoint | stroke or systemic embolism ⓘ |
| primaryObjective | to compare dabigatran with warfarin for stroke prevention in atrial fibrillation ⓘ |
| publicationType | landmark trial in anticoagulation ⓘ |
| resultInterpretation | dabigatran is an effective alternative to warfarin for many patients with atrial fibrillation ⓘ |
| safetyEndpoint | major bleeding ⓘ |
| safetyOutcome |
gastrointestinal bleeding
ⓘ
intracranial hemorrhage ⓘ |
| sponsor | Boehringer Ingelheim NERFINISHED ⓘ |
| therapeuticArea |
cardiology
ⓘ
thrombosis and hemostasis ⓘ |
| warfarinTargetINR | 2.0–3.0 ⓘ |
How these facts were elicited
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Subject: RE-LY trial Description of subject: The RE-LY trial was a large, pivotal clinical study that compared the efficacy and safety of the oral anticoagulant dabigatran with warfarin for stroke prevention in patients with atrial fibrillation.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.