Trial · NCT02239120
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
NCT02239120, Phase 3, Completed, Boehringer Ingelheim; results first posted 2019-09-06
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS). Trials, record NCT02239120. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02239120
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
- NCT number
- NCT02239120
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,390 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Stroke, Secondary Prevention
- Interventions
- optional ASA as comedication, placebo to ASA, placebo to optional ASA as comedication, placebo to dabigatran etexilate, ASA 100 mg, dabigatran etexilate
- First posted
- 2014-09-12
- Last updated
- 2019-09-06
- Other registries' IDs
- eudract:2013-003444-24
- Results first posted
- 2019-09-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjudicated Recurrent Stroke | From randomisation until full follow up period, approximately 43 months. | Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Primary | First Major Bleed (Adjudicated) | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows: * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or, * Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or, * Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Secondary | Adjudicated Ischaemic Stroke | From randomisation until full follow up period, up to 43 months | Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Secondary | Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death | From randomisation until full follow up period, up to 43 months | Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Secondary | Disabling Stroke | From randomisation until full follow up period, up to 43 months | Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Secondary | All-cause Death | From randomisation until full follow up period, up to 43 months | All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Secondary | Adjudicated Intracranial Hemorrhage | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Secondary | Adjudicated Fatal Bleed | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated. |
| Secondary | Adjudicated Life-threatening Bleed | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention. The annualised event rate represents the average number of events per patient during a 1-year period. |
| Secondary | Any Bleed (Investigator-reported) | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity. The annualised event rate represents the average number of events per patient during a 1-year period. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjudicated Recurrent Stroke | From randomisation until full follow up period, approximately 43 months. | Randomised set (RS): RS consisted of all participants who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation. | Annualised event rate (%/ year) | NUMBER |
| PRIMARY | First Major Bleed (Adjudicated) | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | Treated set (TS): TS consisted of all patients who were treated with at least 1 dose of trial medication. The start date of the observation period for this population was the date of first intake of trial medication. | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | Adjudicated Ischaemic Stroke | From randomisation until full follow up period, up to 43 months | RS | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death | From randomisation until full follow up period, up to 43 months | RS | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | Disabling Stroke | From randomisation until full follow up period, up to 43 months | RS | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | All-cause Death | From randomisation until full follow up period, up to 43 months | RS | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | Adjudicated Intracranial Hemorrhage | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | TS | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | Adjudicated Fatal Bleed | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | TS | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | Adjudicated Life-threatening Bleed | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | TS | Annualised event rate (%/ year) | NUMBER |
| SECONDARY | Any Bleed (Investigator-reported) | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | TS | Annualised event rate (%/ year) | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjudicated Recurrent Stroke | Dabigatran Etexilate 110 or 150 Milligram (mg) | 4.09 | Annualised event rate (%/ year) | ||
| Adjudicated Recurrent Stroke | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 4.80 | Annualised event rate (%/ year) | ||
| First Major Bleed (Adjudicated) | Dabigatran Etexilate 110 or 150 Milligram (mg) | 1.84 | Annualised event rate (%/ year) | ||
| First Major Bleed (Adjudicated) | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 1.33 | Annualised event rate (%/ year) | ||
| Adjudicated Ischaemic Stroke | Dabigatran Etexilate 110 or 150 Milligram (mg) | 3.97 | Annualised event rate (%/ year) | ||
| Adjudicated Ischaemic Stroke | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 4.71 | Annualised event rate (%/ year) | ||
| Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death | Dabigatran Etexilate 110 or 150 Milligram (mg) | 4.80 | Annualised event rate (%/ year) | ||
| Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 5.40 | Annualised event rate (%/ year) | ||
| Disabling Stroke | Dabigatran Etexilate 110 or 150 Milligram (mg) | 0.55 | Annualised event rate (%/ year) | ||
| Disabling Stroke | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 0.93 | Annualised event rate (%/ year) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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 Etexilate 110 or 150 Milligram (mg) | 2,695 | |
| Overall Study | STARTED | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 2,695 | |
| Overall Study | COMPLETED | Dabigatran Etexilate 110 or 150 Milligram (mg) | 2,620 | |
| Overall Study | COMPLETED | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 2,623 | |
| Overall Study | NOT COMPLETED | Dabigatran Etexilate 110 or 150 Milligram (mg) | 75 | |
| Overall Study | NOT COMPLETED | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 72 |
Source ClinicalTrials.gov
Adverse events1,284
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 |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Dabigatran Etexilate 110 or 150 Milligram (mg) | 173 | 2,676 | |
| other | Nasopharyngitis | Infections and infestations | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 170 | 2,674 | |
| other | Atrial fibrillation | Cardiac disorders | Dabigatran Etexilate 110 or 150 Milligram (mg) | 136 | 2,676 | |
| other | Atrial fibrillation | Cardiac disorders | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 128 | 2,674 | |
| serious | Anaemia | Blood and lymphatic system disorders | Dabigatran Etexilate 110 or 150 Milligram (mg) | 7 | 2,676 | |
| serious | Anaemia | Blood and lymphatic system disorders | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 3 | 2,674 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Dabigatran Etexilate 110 or 150 Milligram (mg) | 1 | 2,676 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 0 | 2,674 | |
| serious | Acute myocardial infarction | Cardiac disorders | Dabigatran Etexilate 110 or 150 Milligram (mg) | 11 | 2,676 | |
| serious | Acute myocardial infarction | Cardiac disorders | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 8 | 2,674 |
1 to 10 of 1,284Source ClinicalTrials.gov
See all 1,284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran Etexilate 110 or 150 Milligram (mg) | 56 | 2,695 |
| Total, all-cause mortality | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 58 | 2,695 |
| Total, other adverse events | Dabigatran Etexilate 110 or 150 Milligram (mg) | 306 | 2,676 |
| Total, other adverse events | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 295 | 2,674 |
| Total, serious adverse events | Dabigatran Etexilate 110 or 150 Milligram (mg) | 724 | 2,676 |
| Total, serious adverse events | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 740 | 2,674 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 Etexilate 110 or 150 Milligram (mg) vs Acetylsalicylic Acid, Aspirin (ASA) 100 mg: deaths from any cause | Trial comparisons |
| Dabigatran Etexilate 110 or 150 Milligram (mg) vs Acetylsalicylic Acid, Aspirin (ASA) 100 mg: 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT02239120
GET https://conductscience.org/api/trials/v1/NCT02239120/events?page=2