Trial · NCT02100228
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)
NCT02100228, Phase 4, Completed, Pfizer; results first posted 2018-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT02100228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02100228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,500 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Atrial Fibrillation
- Interventions
- Apixaban, Parenteral heparin and/or oral Vitamin K antagonist
- First posted
- 2014-03-31
- Last updated
- 2018-05-23
- Other registries' IDs
- eudract:2014-001231-36
- Results first posted
- 2018-04-10
- Limitations and caveats
- The prioritization of outcome measures is not mentioned in the study documents (Statistical Analysis Plan and Protocol). The prioritization of outcome measures is based on team's discretion.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Acute Stroke Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma). |
| Primary | Number of Participants With Systemic Embolism Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing. |
| Primary | Number of Participants With Major Bleeding Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | 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. |
| Primary | Number of Participants With Clinically Relevant Non-Major Bleeding Events | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life. |
| Primary | Number of Participants With All Cause Death | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | |
| Secondary | Time to First Attempt of Cardioversion | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure. |
| Secondary | Number of Participants With Different Type of Cardioversion Events | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock. |
| Secondary | Number of Cardioversion Attempt of Participants | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission. |
| Secondary | Number of Participants With Their Rhythm Status | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute). |
| Secondary | Duration of Hospital Stay of Participants | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Acute Stroke Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Full analysis set included all randomized participants. | participants | NUMBER |
| PRIMARY | Number of Participants With Systemic Embolism Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Full analysis set included all randomized participants. | participants | NUMBER |
| PRIMARY | Number of Participants With Major Bleeding Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Safety data set included all treated participants (randomized participants who received at least one dose of study drug). | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Relevant Non-Major Bleeding Events | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Safety data set included all treated participants (randomized participants who received at least one dose of study drug). | participants | NUMBER |
| PRIMARY | Number of Participants With All Cause Death | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Full analysis set included all randomized participants. | participants | NUMBER |
| SECONDARY | Time to First Attempt of Cardioversion | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Full analysis set included all randomized participants. Here, N (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure. | days | MEDIAN |
| SECONDARY | Number of Participants With Different Type of Cardioversion Events | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Full analysis set included all randomized participants. Here N signifies number of participants who were evaluable for this specified outcome measure. | participants | NUMBER |
| SECONDARY | Number of Cardioversion Attempt of Participants | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Full analysis set included all randomized participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Their Rhythm Status | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Safety data set included all treated participants (randomized participants who received at least one dose of study drug). Here N signifies number of participants who were evaluable for this specified outcome measure. | participants | NUMBER |
| SECONDARY | Duration of Hospital Stay of Participants | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Full analysis set included all randomized participants. Here N signifies number of participants who were evaluable for this specified outcome measure. | hours | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Acute Stroke Event | Apixaban | 0 | participants | ||
| Number of Participants With Acute Stroke Event | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 6 | participants | ||
| Number of Participants With Systemic Embolism Event | Apixaban | 0 | 0 to 0 | participants | |
| Number of Participants With Systemic Embolism Event | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 0 | 0 to 0 | participants | |
| Number of Participants With Major Bleeding Event | Apixaban | 3 | participants | ||
| Number of Participants With Major Bleeding Event | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 6 | participants | ||
| Number of Participants With Clinically Relevant Non-Major Bleeding Events | Apixaban | 11 | participants | ||
| Number of Participants With Clinically Relevant Non-Major Bleeding Events | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 13 | participants | ||
| Number of Participants With All Cause Death | Apixaban | 2 | participants | ||
| Number of Participants With All Cause Death | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 1 | participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apixaban | 753 | |
| Overall Study | STARTED | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 747 | |
| Overall Study | COMPLETED | Apixaban | 678 | |
| Overall Study | COMPLETED | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 657 | |
| Overall Study | NOT COMPLETED | Apixaban | 75 | |
| Overall Study | NOT COMPLETED | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 90 |
Source ClinicalTrials.gov
Adverse events294
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ATRIAL FIBRILLATION | Cardiac disorders | Apixaban | 43 | 735 | |
| other | ATRIAL FIBRILLATION | Cardiac disorders | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 46 | 721 | |
| other | ATRIAL THROMBOSIS | Cardiac disorders | Apixaban | 17 | 735 | |
| other | ATRIAL THROMBOSIS | Cardiac disorders | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 13 | 721 | |
| other | INTERNATIONAL NORMALISED RATIO ABNORMAL | Investigations | Apixaban | 0 | 735 | |
| other | INTERNATIONAL NORMALISED RATIO ABNORMAL | Investigations | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 19 | 721 | |
| other | INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | Apixaban | 0 | 735 | |
| other | INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 27 | 721 | |
| other | DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Apixaban | 15 | 735 | |
| other | DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 8 | 721 |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apixaban | 1 | 735 |
| Total, all-cause mortality | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 3 | 721 |
| Total, other adverse events | Apixaban | 70 | 735 |
| Total, other adverse events | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 101 | 721 |
| Total, serious adverse events | Apixaban | 100 | 735 |
| Total, serious adverse events | Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 112 | 721 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29659797 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants With Major Bleeding Event | Trial comparisons |
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants With Systemic Embolism Event | Trial comparisons |
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants With Acute Stroke Event | Trial comparisons |
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants With All Cause Death | Trial comparisons |
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): deaths from any cause | Trial comparisons |
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants With Clinically Relevant Non-Major Bleeding Events | Trial comparisons |
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): Number of Participants Who Used Image Guidance Approach | Trial comparisons |
| Apixaban vs Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02100228
GET https://conductscience.org/api/trials/v1/NCT02100228/results?page=2