Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

NCT02313909 on ClinicalTrials.gov Phase 3 Bayer (industry) Started 2014-12-23 Terminated

Riskier than 26% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 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 2018-02-15, after 2014-12-23 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 2018-02-15. 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: braincardiacpatientsischemictherapy
Phrases that lowered it: bloodabuseonce dailystudy willcompare
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 6.2% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 108 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 9.8% (lowers risk) · Drug's FDA history
Disease area, neurology: Yes (raises risk) · Disease area
Drug's FAERS reports marked serious: 75.6% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Minimum age: 50 (lowers risk) · Who can join
Drug's FAERS reports in the prior 12 months: 46848 (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 218596 (lowers risk) · Drug's FDA history
Sponsor's past trials: 535 (lowers risk) · Sponsor's track record
Disease area, cardiovascular: Yes (raises risk) · Disease area
Number of arms: 2 (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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 2 (typical: 0)
Keywords listed: 14 (typical: 1)

Who can join

Minimum age: 50 (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: 535 (typical: 32)
Sponsor's past termination rate: 6.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 108 (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: 218596 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 46848 (typical: 412.5)
Drug's FAERS reports marked serious: 75.6% (typical: 85.6%)
Drug's FAERS reports with a death: 9.8% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular, neurology
Drugs matched to FDA substances: aspirin, rivaroxaban

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

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS) NCT02239120 · started 2014 · scored riskier than 33% of active trials completed
Rivaroxaban Versus Warfarin in Acute Ischemic Stroke With Atrial Fibrillation NCT02042534 · started 2014 · scored riskier than 55% of active trials completed
Apixaban for Treatment of Embolic Stroke of Undetermined Source NCT02427126 · started 2015 · scored riskier than 67% of active trials completed
Rivaroxaban Plus ASA in Embolic Stroke of Undetermined Source(AREST-ESUS) NCT04273516 · started 2020 · scored riskier than 74% of active trials completed
Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease NCT04142125 · started 2020 · scored riskier than 71% 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.