Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2016-11-30, after 2011-06-30 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2016-11-30. 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: to determineheartdetermine whetherarteryarb
Phrases that lowered it: participantsasthmalong termarmdiseases -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 11.8% (raises risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: quadruple (lowers 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
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Drug's FAERS reports marked serious: 73.5% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 7678 (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Collaborators: 1 (raises risk) · Design
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Keywords listed: 5 (lowers risk) · Design
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Drugs with FDA adverse-event history: 2 (lowers risk) · Drug's FDA history
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
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (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
- academic or other
- Sponsor's past trials
- 51 (typical: 32)
- Sponsor's past termination rate
- 11.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 38619 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7678 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- atenolol, telmisartan
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
- Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve NCT02679261 · started 2016 · scored riskier than 41% of active trials completed
- Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS NCT01715207 · started 2010 · scored riskier than 41% of active trials completed
- Pharmacological Reduction of Right Ventricular Enlargement NCT04345796 · started 2021 · scored riskier than 33% of active trials completed
- Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers NCT00782327 · started 2009 · scored riskier than 17% of active trials completed
- Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS) NCT03483051 · started 2018 · scored riskier than 25% 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.