Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (107 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-04-26, after 2018-07-10 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-04-26. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heartmechanicalstrokeactiveanemia
Phrases that lowered it: patients whoresultspatients within patientsimpairment -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Blinding: single (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 13.6% (lowers risk) · Drug's FDA history
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Phase: 2/3 (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 74 (lowers risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports before start: 229520 (lowers risk) · Drug's FDA history
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Responsible party: sponsor (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 74 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 229520 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 40242 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology, hematology
- Drugs matched to FDA substances
- rivaroxaban, warfarin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve. NCT02128841 · started 2012 · scored riskier than 72% of active trials terminated
- RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial NCT02303795 · started 2015 · scored riskier than 77% of active trials completed
- Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes NCT02556203 · started 2015 · scored riskier than 44% of active trials terminated
- Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty NCT01720108 · started 2013 · scored riskier than 48% of active trials completed
- Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH NCT01651780 · started 2012 · scored riskier than 70% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.