Trial · NCT02240667
Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
NCT02240667, Completed, Boehringer Ingelheim; results first posted 2019-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF). Trials, record NCT02240667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02240667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
- NCT number
- NCT02240667
- Status
- Completed
- Enrollment
- 1,506 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- Dabigatran etexilate, Vitamin K antagonists
- First posted
- 2014-09-16
- Last updated
- 2019-04-19
- Results first posted
- 2019-04-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | 12 month (Visit 5) | Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy. |
| Secondary | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | 6 month (visit 3) | Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and \> 2, respectively). |
| Secondary | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment) | Number of patients with the reason for definitive treatment discontinuation |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | 12 month (Visit 5) | Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | 6 month (visit 3) | Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA). | Percentage of participants | NUMBER |
| SECONDARY | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment) | Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | Dabigatran (Dabigatran vs VKA) | 89.5 | 95% Confidence Interval 86.3 to 91.9 | percentage of participants | |
| Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | VKA (Dabigatran vs VKA) | 89.5 | 95% Confidence Interval 86.3 to 92.0 | percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Dabigatran (Dabigatran vs VKA) | Low | 19.12 | Percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | VKA (Dabigatran vs VKA) | Low | 23.74 | Percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Dabigatran (Dabigatran vs VKA) | Medium | 45.8 | Percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | VKA (Dabigatran vs VKA) | Medium | 46.85 | Percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Dabigatran (Dabigatran vs VKA) | High | 5.88 | Percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | VKA (Dabigatran vs VKA) | High | 3.99 | Percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Dabigatran (Dabigatran vs VKA) | Missing | 29.2 | Percentage of participants | |
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | VKA (Dabigatran vs VKA) | Missing | 25.42 | Percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran (Dabigatran vs VKA) | 771 | |
| Overall Study | STARTED | Vitamin K Antagonists (VKA) | 650 | |
| Overall Study | COMPLETED | Dabigatran (Dabigatran vs VKA) | 771 | |
| Overall Study | COMPLETED | Vitamin K Antagonists (VKA) | 650 | |
| Overall Study | NOT COMPLETED | Dabigatran (Dabigatran vs VKA) | 0 | |
| Overall Study | NOT COMPLETED | Vitamin K Antagonists (VKA) | 0 |
Source ClinicalTrials.gov
Adverse events162
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 | Cardiac failure | Cardiac disorders | Dabigatran (Dabigatran vs VKA) | 4 | 771 | |
| serious | Cardiac failure | Cardiac disorders | Vitamin K Antagonists (VKA) | 5 | 650 | |
| serious | Atrial fibrillation | Cardiac disorders | Dabigatran (Dabigatran vs VKA) | 2 | 771 | |
| serious | Atrial fibrillation | Cardiac disorders | Vitamin K Antagonists (VKA) | 3 | 650 | |
| serious | Acute coronary syndrome | Cardiac disorders | Dabigatran (Dabigatran vs VKA) | 1 | 771 | |
| serious | Acute coronary syndrome | Cardiac disorders | Vitamin K Antagonists (VKA) | 4 | 650 | |
| serious | Cardiac arrest | Cardiac disorders | Dabigatran (Dabigatran vs VKA) | 1 | 771 | |
| serious | Cardiac arrest | Cardiac disorders | Vitamin K Antagonists (VKA) | 3 | 650 | |
| serious | Angina pectoris | Cardiac disorders | Dabigatran (Dabigatran vs VKA) | 1 | 771 | |
| serious | Angina pectoris | Cardiac disorders | Vitamin K Antagonists (VKA) | 2 | 650 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran (Dabigatran vs VKA) | 10 | 771 |
| Total, all-cause mortality | Vitamin K Antagonists (VKA) | 5 | 650 |
| Total, other adverse events | Dabigatran (Dabigatran vs VKA) | 0 | 771 |
| Total, other adverse events | Vitamin K Antagonists (VKA) | 0 | 650 |
| Total, serious adverse events | Dabigatran (Dabigatran vs VKA) | 45 | 771 |
| Total, serious adverse events | Vitamin K Antagonists (VKA) | 39 | 650 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dabigatran (Dabigatran vs VKA) vs Vitamin K Antagonists (VKA): deaths from any cause | Trial comparisons |
| Dabigatran (Dabigatran vs VKA) vs Vitamin K Antagonists (VKA): 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/NCT02240667
GET https://conductscience.org/api/trials/v1/NCT02240667/results?page=2