Trial · NCT02164864
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
NCT02164864, Phase 3, Completed, Boehringer Ingelheim; results first posted 2018-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI). Trials, record NCT02164864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02164864
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
- NCT number
- NCT02164864
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,725 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation, Percutaneous Coronary Intervention
- Interventions
- Dabigatran Etexilate 110mg, Warfarin 3mg, Aspirin, Dabigatran Etexilate 150mg, Clopidogrel or Ticagrelor, Clopidogrel or Ticagrelor, Warfarin 5mg, Clopidogrel or Ticagrelor, Warfarin 1mg
- First posted
- 2014-06-17
- Last updated
- 2018-07-31
- Other registries' IDs
- eudract:2013-003201-26
- Results first posted
- 2018-07-31
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Adjudicated ISTH MBE or CRNMBE | up to 30 months | Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'. |
| Secondary | Time to Adjudicated Undetermined Cause of Death | up to 30 months | Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported. This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death. |
| Secondary | Time to Adjudicated Non-CV | up to 30 months | Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported. Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV |
| Secondary | Time to Adjudicated CV | up to 30 months | Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported. CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes. |
| Secondary | Time to Adjudicated All Cause Death | up to 30 months | Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death. |
| Secondary | Time to First Adjudicated MI | up to 30 months | Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported |
| Secondary | Time to First Adjudicated Stroke | up to 30 months | Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported. 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 | Time to First Adjudicated SE | up to 30 months | Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported. SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy. |
| Secondary | Time to First Adjudicated ST | up to 30 months | Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported. |
| Secondary | Time to Composite Endpoint of Death + MI + Stroke | up to 30 months | Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Adjudicated ISTH MBE or CRNMBE | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Adjudicated Undetermined Cause of Death | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Adjudicated Non-CV | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Adjudicated CV | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Adjudicated All Cause Death | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Adjudicated MI | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Adjudicated Stroke | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Adjudicated SE | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Adjudicated ST | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Composite Endpoint of Death + MI + Stroke | up to 30 months | Full Analysis set (FAS) following the intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Adjudicated ISTH MBE or CRNMBE | Dabigatran Etexilate 110mg | 151 | Participants | ||
| Time to First Adjudicated ISTH MBE or CRNMBE | Dabigatran Etexilate 150mg | 154 | Participants | ||
| Time to First Adjudicated ISTH MBE or CRNMBE | Warfarin | 264 | Participants | ||
| Time to First Adjudicated ISTH MBE or CRNMBE | Warfarin (Excluding Elder Patients Outside USA) | 196 | Participants | ||
| Time to Adjudicated Undetermined Cause of Death | Dabigatran Etexilate 110mg | 4 | Participants | ||
| Time to Adjudicated Undetermined Cause of Death | Dabigatran Etexilate 150mg | 5 | Participants | ||
| Time to Adjudicated Undetermined Cause of Death | Warfarin | 4 | Participants | ||
| Time to Adjudicated Undetermined Cause of Death | Warfarin (Excluding Elder Patients Outside USA) | 3 | Participants | ||
| Time to Adjudicated Non-CV | Dabigatran Etexilate 110mg | 14 | Participants | ||
| Time to Adjudicated Non-CV | Dabigatran Etexilate 150mg | 4 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran Etexilate 110mg | 981 | |
| Overall Study | STARTED | Dabigatran Etexilate 150mg | 763 | |
| Overall Study | STARTED | Warfarin | 981 | |
| Overall Study | COMPLETED | Dabigatran Etexilate 110mg | 886 | |
| Overall Study | COMPLETED | Dabigatran Etexilate 150mg | 703 | |
| Overall Study | COMPLETED | Warfarin | 849 | |
| Overall Study | NOT COMPLETED | Dabigatran Etexilate 110mg | 95 | |
| Overall Study | NOT COMPLETED | Dabigatran Etexilate 150mg | 60 | |
| Overall Study | NOT COMPLETED | Warfarin | 132 |
Source ClinicalTrials.gov
Adverse events1,635
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 | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Dabigatran Etexilate 110mg | 62 | 972 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Dabigatran Etexilate 150mg | 60 | 758 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Warfarin | 61 | 948 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Dabigatran Etexilate 110mg | 52 | 972 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Dabigatran Etexilate 150mg | 59 | 758 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Warfarin | 146 | 948 | |
| other | Haematoma | Vascular disorders | Dabigatran Etexilate 110mg | 27 | 972 | |
| other | Haematoma | Vascular disorders | Dabigatran Etexilate 150mg | 24 | 758 | |
| other | Haematoma | Vascular disorders | Warfarin | 60 | 948 | |
| serious | Anaemia | Blood and lymphatic system disorders | Dabigatran Etexilate 110mg | 6 | 972 |
1 to 10 of 1,635Source ClinicalTrials.gov
See all 1,635 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran Etexilate 110mg | 38 | 972 |
| Total, all-cause mortality | Dabigatran Etexilate 150mg | 24 | 758 |
| Total, all-cause mortality | Warfarin | 41 | 948 |
| Total, other adverse events | Dabigatran Etexilate 110mg | 128 | 972 |
| Total, other adverse events | Dabigatran Etexilate 150mg | 126 | 758 |
| Total, other adverse events | Warfarin | 229 | 948 |
| Total, serious adverse events | Dabigatran Etexilate 110mg | 415 | 972 |
| Total, serious adverse events | Dabigatran Etexilate 150mg | 300 | 758 |
| Total, serious adverse events | Warfarin | 396 | 948 |
Source ClinicalTrials.gov
Papers6
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 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/NCT02164864
GET https://conductscience.org/api/trials/v1/NCT02164864/results?page=2