Comparison · NCT02100228-254fe6da
Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants With Major Bleeding Event
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants With Major Bleeding Event. Trial comparisons, record NCT02100228-254fe6da. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02100228-254fe6da
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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 | 0.00408 | 0.00139 | 0.0119 | wilson | |
| Risk in group 2 | 0.00832 | 0.00382 | 0.018 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00424 | -0.0143 | 0.00481 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.49 | 0.123 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 0.488 | 0.122 | 1.96 | log | |
| Number needed to treat, for one fewer participant with the outcome on Apixaban than on Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 236 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Apixaban | Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants. | 3 | 735 | OG000 |
| Group 2 | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice. | 6 | 721 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Major Bleeding Event
- Description
Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.
- Time frame
- Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
- Population
- Safety data set included all treated participants (randomized participants who received at least one dose of study drug).
Source ClinicalTrials.gov
Trial
- Title
- Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)
- NCT number
- NCT02100228
- Phases
- PHASE4
- Conditions
- Atrial Fibrillation
- Interventions
- Apixaban, Parenteral heparin and/or oral Vitamin K antagonist
- Lead sponsor
- Pfizer
- Results first posted
- 2018-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02100228?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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