Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase I
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 11% of the time (234 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 2013-03-31, after 2011-09-30 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 2013-03-31. 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: coronaryventricularpcipatientcells
Phrases that lowered it: plaqueindexinvestigateadministrationdrug -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 6.3% (lowers risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Minimum age: 31 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 99 (lowers 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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Drug's FAERS reports with a death: 7.8% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 69.9% (lowers risk) · Drug's FDA history
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Blinding: single (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Sponsor type: government (raises risk) · Sponsor's track record
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Sponsor's past trials: 63 (lowers risk) · Sponsor's track record
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Keywords listed: 6 (lowers risk) · Design
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Number of arms: 2 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 13899 (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
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 31 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 63 (typical: 32)
- Sponsor's past termination rate
- 6.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 99 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 70480 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13899 (typical: 412.5)
- Drug's FAERS reports marked serious
- 69.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- atorvastatin
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
- Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase II NCT02347098 · started 2015 · scored riskier than 71% of active trials completed
- Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI) NCT01442038 · started 2011 · scored riskier than 85% of active trials completed
- The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL) NCT01500434 · started 2009 · scored riskier than 83% of active trials completed
- The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions NCT00823212 · started 2009 · scored riskier than 82% of active trials completed
- Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting NCT02617290 · started 2017 · scored riskier than 57% 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.