Trial · NCT03006341
Validation of Predictors of OAC Initiation Using EMR Data
NCT03006341, Completed, Boehringer Ingelheim; results first posted 2019-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Validation of Predictors of OAC Initiation Using EMR Data. Trials, record NCT03006341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03006341
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Validation of Predictors of OAC Initiation Using EMR Data
- NCT number
- NCT03006341
- Status
- Completed
- Enrollment
- 140,187 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- Dabigatran etexilate, Warfarin
- First posted
- 2016-12-30
- Last updated
- 2019-03-22
- Results first posted
- 2019-03-22
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Obesity | Up to 12 months | Percentage of patients with obesity; where obesity is defined as "obese, not-obese based on note of obesity or recorded body mass index (BMI) \> 30 in the electronic medical records (EMR)". The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Primary | Percentage of Patients Smoking | Up to 12 months | Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Primary | Percentage of Patients With Alcohol Consumption | Up to 12 months | Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Primary | Percentage of Patients With Abnormal Renal Function | Up to 12 months | Percentage of patients with abnormal renal function; defined as "Any note of: Dialysis, renal transplant Serum Creatinine \>1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR)". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Primary | Percentage of Patients With Bleeding History or Predisposition | Up to 12 months | Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of \> 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Primary | EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) | Up to 12 months | EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Primary | EMR Characteristic: Serum Creatinine | Up to 12 months | EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Primary | Percentage of Patients With Abnormal Liver Function | Up to 12 months | Percentage of patients with abnormal liver function; defined as "Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) \>3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Secondary | EMR Characteristic: Duration of Atrial Fibrillation | Up to 12 months | EMR characteristic: Duration of atrial fibrillation (Years / months prior to initiation of Dabigatran / Warfarin). Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Secondary | EMR Characteristic: History of Adherence: Non-adherent/Adherent | Up to 12 months | EMR characteristic: History of adherence: non-adherent/adherent. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Obesity | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Smoking | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients With Alcohol Consumption | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients With Abnormal Renal Function | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients With Bleeding History or Predisposition | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Percentage of patients | NUMBER |
| PRIMARY | EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Milliliter/minute/1.73 square meter | MEAN |
| PRIMARY | EMR Characteristic: Serum Creatinine | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Milligrams per deciliter | MEAN |
| PRIMARY | Percentage of Patients With Abnormal Liver Function | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. | Percentage of patients | NUMBER |
| SECONDARY | EMR Characteristic: Duration of Atrial Fibrillation | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Duration calculated for patients identified as having condition in EMR. | Months | MEAN |
| SECONDARY | EMR Characteristic: History of Adherence: Non-adherent/Adherent | Up to 12 months | Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Although the original intent was to document the patient's history of adherence, no such information was available in the EMR |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Obesity | Dabigatran Etexilate | Before PS matching | 58.2 | Percentage of patients | |
| Percentage of Patients With Obesity | Warfarin | Before PS matching | 51.7 | Percentage of patients | |
| Percentage of Patients With Obesity | Dabigatran Etexilate | After PS matching | 57.4 | Percentage of patients | |
| Percentage of Patients With Obesity | Warfarin | After PS matching | 54.2 | Percentage of patients | |
| Percentage of Patients Smoking | Dabigatran Etexilate | Before PS matching | 50.0 | Percentage of patients | |
| Percentage of Patients Smoking | Warfarin | Before PS matching | 51.8 | Percentage of patients | |
| Percentage of Patients Smoking | Dabigatran Etexilate | After PS matching | 50.0 | Percentage of patients | |
| Percentage of Patients Smoking | Warfarin | After PS matching | 50.5 | Percentage of patients | |
| Percentage of Patients With Alcohol Consumption | Dabigatran Etexilate | Before PS matching | 47.1 | Percentage of patients | |
| Percentage of Patients With Alcohol Consumption | Warfarin | Before PS matching | 50.9 | Percentage of patients |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran Etexilate | 26,199 | |
| Overall Study | STARTED | Warfarin | 70,071 | |
| Overall Study | STARTED | Rivaroxaban | 32,595 | |
| Overall Study | STARTED | Apixaban | 11,322 | |
| Overall Study | COMPLETED | Dabigatran Etexilate | 1,130 | |
| Overall Study | COMPLETED | Warfarin | 2,566 | |
| Overall Study | COMPLETED | Rivaroxaban | 1,602 | |
| Overall Study | COMPLETED | Apixaban | 637 | |
| Overall Study | NOT COMPLETED | Dabigatran Etexilate | 25,069 | |
| Overall Study | NOT COMPLETED | Warfarin | 67,505 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran Etexilate | 0 | 0 |
| Total, all-cause mortality | Warfarin | 0 | 0 |
| Total, all-cause mortality | Rivaroxaban | 0 | 0 |
| Total, all-cause mortality | Apixaban | 0 | 0 |
| Total, other adverse events | Dabigatran Etexilate | 0 | 0 |
| Total, other adverse events | Warfarin | 0 | 0 |
| Total, other adverse events | Rivaroxaban | 0 | 0 |
| Total, other adverse events | Apixaban | 0 | 0 |
| Total, serious adverse events | Dabigatran Etexilate | 0 | 0 |
| Total, serious adverse events | Warfarin | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03006341
GET https://conductscience.org/api/trials/v1/NCT03006341/results?page=2