Trial · NCT01774370
SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
NCT01774370, Completed, Boehringer Ingelheim; results first posted 2019-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea. Trials, record NCT01774370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01774370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
- NCT number
- NCT01774370
- Status
- Completed
- Enrollment
- 3,182 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- Pradaxa (Dabigatran etexilate mesilate)
- First posted
- 2013-01-24
- Last updated
- 2019-03-08
- Results first posted
- 2019-03-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality) | up to 26 weeks | Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality). Number analyzed presents the "Number of participants with Adverse events" |
| Secondary | Percentage of Participants With Stroke | up to 26 weeks | Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. |
| Secondary | Percentage of Participants With Systemic Embolism | up to 26 weeks | Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy. |
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 | Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality) | up to 26 weeks | Safety analyses will be based on all patients treated, i.e. all patients who received at least one dose of Pradaxa. | Adverse events | NUMBER |
| SECONDARY | Percentage of Participants With Stroke | up to 26 weeks | Effectiveness Analysis set: Effectiveness analysis will be performed to the patients who have been on Pradaxa more than 12 weeks (in case of long-term follow up, 24 weeks). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Systemic Embolism | up to 26 weeks | Effectiveness Analysis set | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality) | Pradaxa Group | 871 | Adverse events | ||
| Percentage of Participants With Stroke | Pradaxa Group | Yes | 0.30 | percentage of participants | |
| Percentage of Participants With Stroke | Pradaxa Group | No | 99.70 | percentage of participants | |
| Percentage of Participants With Systemic Embolism | Group not reported | Yes | percentage of participants | ||
| Percentage of Participants With Systemic Embolism | Pradaxa Group | No | 100.0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pradaxa Group | 3,182 | |
| Overall Study | COMPLETED | Pradaxa Group | 3,053 | |
| Overall Study | NOT COMPLETED | Pradaxa Group | 129 |
Source ClinicalTrials.gov
Adverse events81
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 | Dyspepsia | Gastrointestinal disorders | Pradaxa Group | 2 | 3,053 | |
| serious | Gastritis | Gastrointestinal disorders | Pradaxa Group | 1 | 3,053 | |
| serious | Haematochezia | Gastrointestinal disorders | Pradaxa Group | 3 | 3,053 | |
| serious | Gastric ulcer | Gastrointestinal disorders | Pradaxa Group | 1 | 3,053 | |
| serious | Colitis ischaemic | Gastrointestinal disorders | Pradaxa Group | 1 | 3,053 | |
| serious | Duodenal ulcer haemorrhage | Gastrointestinal disorders | Pradaxa Group | 1 | 3,053 | |
| serious | Haematemesis | Gastrointestinal disorders | Pradaxa Group | 1 | 3,053 | |
| serious | Ileus paralytic | Gastrointestinal disorders | Pradaxa Group | 1 | 3,053 | |
| serious | Large intestine polyp | Gastrointestinal disorders | Pradaxa Group | 1 | 3,053 | |
| serious | Dizziness | Nervous system disorders | Pradaxa Group | 1 | 3,053 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pradaxa Group | 5 | 3,053 |
| Total, other adverse events | Pradaxa Group | 0 | 3,053 |
| Total, serious adverse events | Pradaxa Group | 104 | 3,053 |
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 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/NCT01774370
GET https://conductscience.org/api/trials/v1/NCT01774370/events?page=2