PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-12-12, after 2020-05-01 start.
Reason given by the sponsor: “safety”
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 2022-12-12. 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: activewomen ofinrto determineanticoagulation
Phrases that lowered it: participantsscreeningfemalemalefood -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 13.0% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 76.4% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 241204 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Number of arms: 2 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 241204 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 41948 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- apixaban, 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
- Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis NCT02664649 · started 2016 · scored riskier than 70% of active trials completed
- INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority NCT02832544 · started 2016 · scored riskier than 56% of active trials completed
- A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke NCT05643573 · started 2022 · scored riskier than 54% of active trials terminated
- Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy NCT01758640 · started 2010 · scored riskier than 21% of active trials completed
- A Pilot Study on Edoxaban for the Resolution of Left Atrial Thrombosis in Patients With Non-valvular Atrial Fibrillation NCT03489395 · started 2018 · scored riskier than 66% 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.