Comparison · NCT00559988-a81b1ced
Home Monitoring Guided OAC vs Physician-Directed OAC: Rate of Major Bleeding Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Home Monitoring Guided OAC vs Physician-Directed OAC: Rate of Major Bleeding Events. Trial comparisons, record NCT00559988-a81b1ced. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00559988-a81b1ced
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0339 | 0.0255 | 0.0449 | wilson | |
| Risk in group 2 | 0.025 | 0.0179 | 0.0347 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00892 | -0.00393 | 0.022 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.877 | 2.1 | log | |
| Odds ratio, group 1 over group 2 | 1.37 | 0.873 | 2.15 | log | |
| Number needed to treat, for one more participant with the outcome on Home Monitoring Guided OAC than on Physician-Directed OAC | 112 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Home Monitoring Guided OAC | Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy. | 46 | 1,357 | OG000 |
| Group 2 | Physician-Directed OAC | In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care. | 34 | 1,361 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Rate of Major Bleeding Events
- Description
- Time frame
- Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
- Population
Source ClinicalTrials.gov
Trial
- Title
- Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
- NCT number
- NCT00559988
- Phases
- PHASE4
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial, Major Bleeding
- Interventions
- Home Monitoring Guided OAC, Physician-Directed OAC
- Lead sponsor
- Biotronik, Inc.
- Results first posted
- 2014-06-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00559988?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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