NCT02081807 is a clinical trial in Atrial Fibrillation, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02081807?

NCT02081807 is sponsored by Boehringer Ingelheim.

What condition does NCT02081807 study?

NCT02081807 studies Atrial Fibrillation.

Is NCT02081807 still recruiting?

NCT02081807 is currently completed. Last updated 2 October 2019.

Are results published for NCT02081807?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-02 · How we verify

NCT02081807

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sequential Expansion of Comparative Effectiveness of Anticoagulants

Completed Results posted Last updated 2 October 2019

What this trial tests

trial in Atrial Fibrillation in 221,228 participants. Completed in 1 November 2017.

Timeline

7 March 2014

Primary endpoint
1 November 2017

1 November 2017

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	221,228
Start date	7 March 2014
Primary completion	1 November 2017
Estimated completion	1 November 2017
Sites	1 location across United States

Conditions studied

Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification) Primary · From October 2010 to September 2015 (the study period)

The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebr

Group	Value	95% CI
Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran)	0.90	0.60 – 1.30
Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin)	1.01	0.66 – 1.50
MarketScan - Dabigatran vs. Warfarin (Dabigatran)	0.64	0.51 – 0.80
MarketScan - Dabigatran vs. Warfarin (Warfarin)	0.99	0.80 – 1.20
Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban)	0.80	0.56 – 1.11
Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin)	1.02	0.72 – 1.39
MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban)	0.78	0.64 – 0.94
MarketScan - Rivaroxaban vs. Warfarin (Warfarin)	1.09	0.90 – 1.31
Optum Clinformatics - Apixaban vs. Warfarin (Apixaban)	1.08	0.74 – 1.53
Optum Clinformatics - Apixaban vs. Warfarin (Warfarin)	1.26	0.86 – 1.80
MarketScan - Apixaban vs. Warfarin (Apixaban)	0.62	0.44 – 0.84
MarketScan - Apixaban vs. Warfarin (Warfarin)	1.16	0.87 – 1.51

Major Bleeding Primary · From October 2010 to September 2015 (the study period)

The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).

Group	Value	95% CI
Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran)	2.43	1.91 – 3.05
Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin)	5.23	4.35 – 6.24
MarketScan - Dabigatran vs. Warfarin (Dabigatran)	4.36	4.00 – 4.74
MarketScan - Dabigatran vs. Warfarin (Warfarin)	6.06	5.58 – 6.56
Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban)	6.2	5.5 – 7.0
Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin)	6.3	5.5 – 7.2
MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban)	6.9	6.5 – 7.4
MarketScan - Rivaroxaban vs. Warfarin (Warfarin)	7.5	7.0 – 8.0
Optum Clinformatics - Apixaban vs. Warfarin (Apixaban)	3.33	2.69 – 4.07
Optum Clinformatics - Apixaban vs. Warfarin (Warfarin)	6.83	5.80 – 7.99
MarketScan - Apixaban vs. Warfarin (Apixaban)	4.25	3.74 – 4.80
MarketScan - Apixaban vs. Warfarin (Warfarin)	7.96	7.15 – 8.83

Stroke or Systemic Embolism Secondary · From October 2010 to September 2015 (the study period)

The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification).

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	0.92	0.77 – 1.08
Dabigatran vs. Warfarin (Warfarin)	1.13	0.95 – 1.33
Rivaroxaban vs. Warfarin (Rivaroxaban)	1.00	0.85 – 1.15
Rivaroxaban vs. Warfarin (Warfarin)	1.29	1.11 – 1.50
Apixaban vs. Warfarin (Apixaban)	0.81	0.63 – 1.02
Apixaban vs. Warfarin (Warfarin)	1.36	1.10 – 1.66

Systemic Embolism Secondary · From October 2010 to September 2015 (the study period)

The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 Diagnoses: 444.x Arterial embolism.

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	0.23	0.17 – 0.32
Dabigatran vs. Warfarin (Warfarin)	0.14	0.08 – 0.22
Rivaroxaban vs. Warfarin (Rivaroxaban)	0.21	0.15 – 0.29
Rivaroxaban vs. Warfarin (Warfarin)	0.22	0.15 – 0.32
Apixaban vs. Warfarin (Apixaban)	0.05	0.02 – 0.11
Apixaban vs. Warfarin (Warfarin)	0.17	0.09 – 0.29

Ischemic Stroke Secondary · From October 2010 to September 2015 (the study period)

The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	0.63	0.51 – 0.76
Dabigatran vs. Warfarin (Warfarin)	0.80	0.65 – 0.97
Rivaroxaban vs. Warfarin (Rivaroxaban)	0.63	0.52 – 0.75
Rivaroxaban vs. Warfarin (Warfarin)	0.90	0.75 – 1.07
Apixaban vs. Warfarin (Apixaban)	0.61	0.46 – 0.79
Apixaban vs. Warfarin (Warfarin)	1.03	0.80 – 1.29

Hemorrhagic Stroke Secondary · From October 2010 to September 2015 (the study period)

The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH)

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	0.07	0.03 – 0.12
Dabigatran vs. Warfarin (Warfarin)	0.19	0.12 – 0.28
Rivaroxaban vs. Warfarin (Rivaroxaban)	0.18	0.12 – 0.25
Rivaroxaban vs. Warfarin (Warfarin)	0.18	0.12 – 0.26
Apixaban vs. Warfarin (Apixaban)	0.15	0.09 – 0.25
Apixaban vs. Warfarin (Warfarin)	0.18	0.10 – 0.31

Stroke Uncertain Classification Secondary · From October 2010 to September 2015 (the study period)

The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease).

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	0.00	0.00 – 0.02
Dabigatran vs. Warfarin (Warfarin)	0.00	0.00 – 0.02
Rivaroxaban vs. Warfarin (Rivaroxaban)	0.00	0.00 – 0.01
Rivaroxaban vs. Warfarin (Warfarin)	0.00	0.00 – 0.02
Apixaban vs. Warfarin (Apixaban)	0.00	0.00 – 0.03
Apixaban vs. Warfarin (Warfarin)	0.00	0.00 – 0.04

Major Intracranial Bleeding Secondary · From October 2010 to September 2015 (the study period)

The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 diagnosis: 430.x Subarachnoid hemorrhage (SAH), 431.x Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	0.21	0.15 – 0.30
Dabigatran vs. Warfarin (Warfarin)	0.58	0.46 – 0.73
Rivaroxaban vs. Warfarin (Rivaroxaban)	0.44	0.35 – 0.55
Rivaroxaban vs. Warfarin (Warfarin)	0.66	0.53 – 0.81
Apixaban vs. Warfarin (Apixaban)	0.45	0.32 – 0.60
Apixaban vs. Warfarin (Warfarin)	0.69	0.51 – 0.92

Major Extra-cranial Bleeding Secondary · From October 2010 to September 2015 (the study period)

The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	3.78	3.48 – 4.10
Dabigatran vs. Warfarin (Warfarin)	5.37	4.96 – 5.79
Rivaroxaban vs. Warfarin (Rivaroxaban)	6.31	5.94 – 6.69
Rivaroxaban vs. Warfarin (Warfarin)	6.54	6.11 – 6.99
Apixaban vs. Warfarin (Apixaban)	3.51	3.13 – 3.92
Apixaban vs. Warfarin (Warfarin)	6.92	6.31 – 7.58

Major Gastrointestinal (GI) Bleeding Secondary · From October 2010 to September 2015 (the study period)

The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding).

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	2.39	2.15 – 2.65
Dabigatran vs. Warfarin (Warfarin)	2.82	2.53 – 3.13
Rivaroxaban vs. Warfarin (Rivaroxaban)	3.82	3.53 – 4.12
Rivaroxaban vs. Warfarin (Warfarin)	3.43	3.13 – 3.76
Apixaban vs. Warfarin (Apixaban)	1.99	1.70 – 2.30
Apixaban vs. Warfarin (Warfarin)	3.59	3.16 – 4.07

Major Upper Gastrointestinal Bleeding Secondary · From October 2010 to September 2015 (the study period)

The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	0.51	0.41 – 0.64
Dabigatran vs. Warfarin (Warfarin)	0.90	0.74 – 1.08
Rivaroxaban vs. Warfarin (Rivaroxaban)	0.99	0.85 – 1.15
Rivaroxaban vs. Warfarin (Warfarin)	0.88	0.73 – 1.05
Apixaban vs. Warfarin (Apixaban)	0.64	0.49 – 0.83
Apixaban vs. Warfarin (Warfarin)	0.89	0.68 – 1.14

Major Lower Gastrointestinal Bleeding Secondary · From October 2010 to September 2015 (the study period)

The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02, Diverticulitis of small intestine with hemorrhage: 562.03, Diverticulosis of colon with hemorrhage: 562.12, Diverticulitis of colon with hemorrhage: 562.13

Group	Value	95% CI
Dabigatran vs. Warfarin (Dabigatran)	2.18	1.96 – 2.43
Dabigatran vs. Warfarin (Warfarin)	2.48	2.21 – 2.77
Rivaroxaban vs. Warfarin (Rivaroxaban)	3.40	3.13 – 3.69
Rivaroxaban vs. Warfarin (Warfarin)	3.09	2.80 – 3.39
Apixaban vs. Warfarin (Apixaban)	1.61	1.36 – 1.90
Apixaban vs. Warfarin (Warfarin)	3.17	2.76 – 3.62

Sponsor's own description

This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Claims Data Studies of Direct Oral Anticoagulants Can Achieve Balance in Important Clinical Parameters Only Observable in Electronic Health Records.
Huybrechts KF, Gopalakrishnan C, Franklin JM, Zint K, et al · · 2019 · cited 11× · PMID 30341980 · DOI 10.1002/cpt.1256
Effectiveness of Novel Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis.
Patel P, Patel SH, Siddegowda A, Potini BR, et al · · 2024 · PMID 38947715 · DOI 10.7759/cureus.61374

Verify or expand the search:

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

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NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
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NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02081807 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 2 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02081807.

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