Randomized Controlled Trial of Argatroban With Tissue Plasminogen Activator (tPA) for Acute Stroke
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 10% 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 (446 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 2015-06-11, after 2011-10-31 start.
Reason given by the sponsor: “other”
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 2015-06-11. 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: headmyocardialarteryinfarctionagents
Phrases that lowered it: mmhgbloodpressurerandomizedtrial to -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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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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Disease area, neurology: Yes (raises risk) · Disease area
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Blinding: single (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: sponsor investigator (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 22.6% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Keywords listed: 5 (lowers 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
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: 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
- 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
- 690 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 134 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology
- Drugs matched to FDA substances
- alteplase, argatroban, plasminogen
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
- Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke NCT02448069 · started 2015 · scored riskier than 93% of active trials completed
- Multi-arm Optimization of Stroke Thrombolysis NCT03735979 · started 2019 · scored riskier than 94% of active trials completed
- Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR) NCT01977456 · started 2013 · scored riskier than 78% of active trials completed
- Acute Ischemic Stroke Interventional Study NCT03803007 · started 2019 · scored riskier than 80% of active trials completed
- Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke NCT04734548 · started 2020 · scored riskier than 56% 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.