A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)

NCT01334918 on ClinicalTrials.gov Phase 2 Astellas Pharma Inc (industry) Started 2011-04-26 Completed

Riskier than 28% of active trials

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 4% 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 (389 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 2012-07-02, after 2011-04-26 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 2012-07-02. 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: subject hasheartsubject isimaginghours
Phrases that lowered it: subjectsasthmavisitcomparesmoking
Design: crossover (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Sponsor's past termination rate: 5.8% (lowers risk) · Sponsor's track record
Primary purpose: diagnostic (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 119 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Sponsor's past trials: 278 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 3.6% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 62.2% (lowers risk) · Drug's FDA history
Minimum age: 45 (lowers risk) · Who can join
Number of arms: 2 (raises risk) · Design
Blinding: none (raises 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: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: diagnostic (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 45 (typical: 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: 278 (typical: 32)
Sponsor's past termination rate: 5.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 119 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 386 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 76 (typical: 412.5)
Drug's FAERS reports marked serious: 62.2% (typical: 85.6%)
Drug's FAERS reports with a death: 3.6% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
Drugs matched to FDA substances: regadenoson, technetium tc99m, tetrofosmin

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

A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT) NCT01618669 · started 2012 · scored riskier than 45% of active trials completed
Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) NCT00826280 · started 2009 · scored riskier than 32% of active trials completed
Stress Echocardiography Study With Regadenoson NCT00907764 · started 2009 · scored riskier than 25% of active trials terminated
Regadenoson R-T Perfusion Imaging Trial NCT00837369 · started 2009 · scored riskier than 76% of active trials completed
Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI NCT00990327 · started 2009 · scored riskier than 44% 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.