Trial · NCT04234698
Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia
NCT04234698, Completed, Pfizer; results first posted 2025-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia. Trials, record NCT04234698. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04234698
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia
- NCT number
- NCT04234698
- Status
- Completed
- Enrollment
- 2,076 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Atrial Fibrillation
- First posted
- 2020-01-21
- Last updated
- 2025-02-06
- Results first posted
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Diagnose NVAF by Each OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Primary | Number of Participants With Comorbidities | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Participants classified according to the comorbidities they had were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. One participant may have more than one comorbidity. |
| Primary | Number of Participants With Uncontrolled Hypertension at OAC Prescription Date | At index date (any time between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Primary | Number of Participants With Use of Aspirin at Start OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Primary | Number of Participants With Use of Clopidogrel at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Primary | Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. In this study Aspirin was not considered as NSAID due to doses used in Colombia. |
| Primary | HAS-BLED Score at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | The risk of bleeding in participants was assessed using Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR, Elderly, (age \>65 years), Drugs or alcohol (HAS-BLED) score. Score ranged from 0 to 8 with higher scores indicating greater risk of bleeding. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Primary | CHA2DS2-VASc Score at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | The CHA2DS2-VASc scale is an evaluation of stroke risk in participants with atrial fibrillation. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score , with total scores ranging from 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Primary | Number of Participants With Anemia at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Primary | Number of Participants With Stroke | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Diagnose NVAF by Each OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Days | MEAN |
| PRIMARY | Number of Participants With Comorbidities | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Uncontrolled Hypertension at OAC Prescription Date | At index date (any time between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Use of Aspirin at Start OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Use of Clopidogrel at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | HAS-BLED Score at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Units on a scale | MEAN |
| PRIMARY | CHA2DS2-VASc Score at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Units on a scale | MEAN |
| PRIMARY | Number of Participants With Anemia at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Stroke | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group214
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Diagnose NVAF by Each OAC Treatment | Warfarin | 71 | Standard Deviation 230.8 | Days | |
| Time to Diagnose NVAF by Each OAC Treatment | NOACs - Rivaroxaban | 324 | Standard Deviation 712.2 | Days | |
| Time to Diagnose NVAF by Each OAC Treatment | NOACs - Apixaban | 218 | Standard Deviation 541.2 | Days | |
| Time to Diagnose NVAF by Each OAC Treatment | NOACs - Dabigatran | 406 | Standard Deviation 676.0 | Days | |
| Number of Participants With Comorbidities | Warfarin | Diabetes Mellitus | 100 | Participants | |
| Number of Participants With Comorbidities | NOACs | Diabetes Mellitus | 370 | Participants | |
| Number of Participants With Comorbidities | Warfarin | Liver Disease | 5 | Participants | |
| Number of Participants With Comorbidities | NOACs | Liver Disease | 25 | Participants | |
| Number of Participants With Comorbidities | Warfarin | Hypertension | 386 | Participants | |
| Number of Participants With Comorbidities | NOACs | Hypertension | 1430 | Participants |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Warfarin | 459 | |
| Overall Study | STARTED | NOACs | 1,617 | |
| Overall Study | COMPLETED | Warfarin | 459 | |
| Overall Study | COMPLETED | NOACs | 1,617 | |
| Overall Study | NOT COMPLETED | Warfarin | 0 | |
| Overall Study | NOT COMPLETED | NOACs | 0 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Gastrointestinal bleeding | Blood and lymphatic system disorders | Warfarin | 19 | 459 | |
| serious | Gastrointestinal bleeding | Blood and lymphatic system disorders | NOACs | 23 | 1,617 | |
| serious | Other major bleeding | Blood and lymphatic system disorders | Warfarin | 17 | 459 | |
| serious | Other major bleeding | Blood and lymphatic system disorders | NOACs | 19 | 1,617 | |
| serious | Hemorrhagic cerebrovascular event | Blood and lymphatic system disorders | Warfarin | 5 | 459 | |
| serious | Hemorrhagic cerebrovascular event | Blood and lymphatic system disorders | NOACs | 2 | 1,617 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Warfarin | 1 | 459 |
| Total, all-cause mortality | NOACs | 5 | 1,617 |
| Total, other adverse events | Warfarin | 0 | 0 |
| Total, other adverse events | NOACs | 0 | 0 |
| Total, serious adverse events | Warfarin | 41 | 459 |
| Total, serious adverse events | NOACs | 44 | 1,617 |
Source ClinicalTrials.gov
Papers0
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 comparisons15
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Warfarin vs NOACs: Number of Participants With Use of Clopidogrel at Start of OAC Treatment | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Treatment Discontinuation | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Gastrointestinal Bleeding | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Use of Aspirin at Start OAC Treatment | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Stroke | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Intracranial Bleeding | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Uncontrolled Hypertension at OAC Prescription Date | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Pulmonary Embolism | Trial comparisons |
| Warfarin vs NOACs: Number of Participants With Other Major Bleeding | Trial comparisons |
1 to 10 of 15
See all 15 trial comparisonsTests0
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/NCT04234698
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