Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease

NCT01946815 on ClinicalTrials.gov Phase 3 Keimyung University Dongsan Medical Center (academic or other) Started 2013-09-30 Completed

Riskier than 65% of active trials

Model scores of the 29,894 trials active now.

Model score 19% 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 2018-11-30, after 2013-09-30 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 2018-11-30. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: coronaryarterytherapypatientleft
Phrases that lowered it: patients whopatients withevaluate theto evaluateeffect
Accepts healthy volunteers: No (raises risk) · Who can join
Collaborators: 3 (lowers risk) · Design
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Minimum age: 19 (lowers risk) · Who can join
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
Responsible party: principal investigator (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 101804 (lowers risk) · Drug's FDA history
Number of arms: 1 (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports marked serious: 70.4% (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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 3 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 19 (typical: 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: 4 (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: 101804 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 14206 (typical: 412.5)
Drug's FAERS reports marked serious: 70.4% (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: atorvastatin

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

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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.