NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH
Model scores of the 29,894 trials active now.
Model score 13% 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 15% of the time (446 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-02-18, after 2017-04-26 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2020-02-18. 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: hemorrhagestroketo determineatrialfibrillation
Phrases that lowered it: and safetyefficacy andstudy tothe efficacysafety of -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 4.5% (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Minimum age: 45 (lowers risk) · Who can join
-
Blinding: single (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 9.5% (lowers risk) · Drug's FDA history
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Responsible party: principal investigator (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 72.0% (lowers risk) · Drug's FDA history
-
Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports in the prior 12 months: 59013 (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (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
- academic or other
- Sponsor's past trials
- 22 (typical: 32)
- Sponsor's past termination rate
- 4.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 327053 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 59013 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology
- Drugs matched to FDA substances
- aspirin
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
- Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist NCT02866838 · started 2016 · scored riskier than 92% of active trials completed
- Apixaban After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation NCT02565693 · started 2014 · scored riskier than 70% 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
- PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation NCT03996772 · started 2019 · scored riskier than 61% of active trials completed
- A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention NCT01830543 · started 2013 · scored riskier than 63% 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.