PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 8% 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
Completed on 2019-02-28, after 2013-10-31 start.
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 2019-02-28. 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: dlcoronaryplateletdefined bycreatinine
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacybody -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Minimum age: 20 (lowers risk) · Who can join
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Primary purpose: prevention (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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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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Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Sponsor's past trials: 4 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 90.4% (raises 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
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- 12658 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2805 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- clopidogrel, prasugrel
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
- High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI) NCT01835353 · started 2012 · scored riskier than 18% of active trials completed
- High Clopidogrel Dose Versus Prasugrel and Ticagrelor in High Reactive Stable Patients NCT01543932 · started 2012 · scored riskier than 23% of active trials completed
- Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention NCT01609647 · started 2012 · scored riskier than 14% of active trials completed
- Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI) NCT00910299 · started 2009 · scored riskier than 27% of active trials terminated
- Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity NCT00638326 · started 2008 · scored riskier than 30% 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.