Bivalirudin Infusion for Ventricular Infarction Limitation
Model scores of the 29,894 trials active now.
Model score 16% 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 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 2016-06-14, after 2014-12-19 start.
Reason given by the sponsor: “efficacy”
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 2016-06-14. 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: heartcancerrandomizationivprior
Phrases that lowered it: mgparticipantweightkgdose -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.1% (raises 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: 27.1% (raises risk) · Drug's FDA history
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Blinding: single (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 85.1% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
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
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 27 (typical: 32)
- Sponsor's past termination rate
- 11.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 24434 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2428 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- bivalirudin, heparin
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
- European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial NCT01087723 · started 2010 · scored riskier than 54% of active trials completed
- STEMI Treated With Primary Angioplasty and Intravenous Lovenox or Unfractionated Heparin (UFH) NCT00718471 · started 2008 · scored riskier than 94% of active trials completed
- The STREAM Percutaneous Coronary Intervention Anticoagulant Sub-study NCT00882635 · started 2008 · scored riskier than 81% of active trials completed
- A Multicenter Trial to Assess the MIcrovascular Integrity and Left Ventricular Function Recovery After Clopidogrel or TicagrelOr Administration, in Patients With STEMI Treated With Thrombolysis - The 'MIRTOS' Study NCT02429271 · started 2015 · scored riskier than 61% of active trials completed
- IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack NCT06139328 · started 2023 · scored riskier than 62% of active trials terminated
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.