Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 1% 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
Completed on 2018-08-14, after 2014-11-27 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 2018-08-14. 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: braincardiacrandomizationpatientsatrial
Phrases that lowered it: investigatorand safetyoralthe trialefficacy and -
Sponsor's past termination rate: 5.4% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 134 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 15.1% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 70.2% (lowers risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Sponsor's past trials: 298 (lowers risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: prevention (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Maximum age: 150 (lowers risk) · Who can join
-
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
- single group (typical: parallel)
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 150 (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
- 298 (typical: 32)
- Sponsor's past termination rate
- 5.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 134 (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
- 37021 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8144 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology
- Drugs matched to FDA substances
- dabigatran, dabigatran etexilate
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
- 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
- AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke NCT03192215 · started 2018 · scored riskier than 82% of active trials terminated
- Early Administration of Edoxaban After Acute Ischemic Stroke in Patients With Non-valvular Atrial Fibrillation NCT03433235 · started 2018 · scored riskier than 33% of active trials completed
- Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS) NCT02313909 · started 2014 · scored riskier than 26% 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.