Trial · NCT02556203
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
NCT02556203, Phase 3, Terminated, Bayer; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes. Trials, record NCT02556203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02556203
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
- NCT number
- NCT02556203
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,653 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Transcatheter Aortic Valve Replacement
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA), Clopidogrel, Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA)
- First posted
- 2015-09-22
- Last updated
- 2020-01-13
- Other registries' IDs
- eudract:2015-001975-30
- Results first posted
- 2020-01-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Death or First Thromboembolic Event (DTE) | Through study completion, on average 14 months | Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism. |
| Primary | Number of Participants With Death or First Thromboembolic Event (DTE) | Through study completion, on average 16 months | Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism. |
| Primary | Number of Participants With Primary Bleeding Event (PBE) | Through study completion, on average 16 months | PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding. |
| Secondary | Number of Participants With Net-clinical Benefit | Through study completion, on average 16 months | The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety). |
| Secondary | Number of Participants With Cardiovascular Death or Thromboembolic Event | Through study completion, on average 16 months | Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication). |
| Secondary | Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds | Through study completion, on average 16 months | Composite of TIMI major and minor bleedings |
| Secondary | Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds | Through study completion, on average 16 months | ISTH major bleeds |
| Secondary | Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds | Through study completion, on average 16 months | Composite of BARC 2,3 or 5 bleedings |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Death or First Thromboembolic Event (DTE) | Through study completion, on average 14 months | Safety analysis set (SAF): Included all randomized subjects who had been exposed to study drug at least once (1608 subjects overall). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Death or First Thromboembolic Event (DTE) | Through study completion, on average 16 months | Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Primary Bleeding Event (PBE) | Through study completion, on average 16 months | Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Net-clinical Benefit | Through study completion, on average 16 months | Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cardiovascular Death or Thromboembolic Event | Through study completion, on average 16 months | Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds | Through study completion, on average 16 months | Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds | Through study completion, on average 16 months | Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds | Through study completion, on average 16 months | Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Death or First Thromboembolic Event (DTE) | Rivaroxaban (Xarelto, BAY59-7939) | 68 | Participants | ||
| Number of Participants With Death or First Thromboembolic Event (DTE) | Antiplatelet | 63 | Participants | ||
| Number of Participants With Death or First Thromboembolic Event (DTE) | Rivaroxaban (Xarelto, BAY59-7939) | 105 | Participants | ||
| Number of Participants With Death or First Thromboembolic Event (DTE) | Antiplatelet | 78 | Participants | ||
| Number of Participants With Primary Bleeding Event (PBE) | Rivaroxaban (Xarelto, BAY59-7939) | 46 | Participants | ||
| Number of Participants With Primary Bleeding Event (PBE) | Antiplatelet | 31 | Participants | ||
| Number of Participants With Net-clinical Benefit | Rivaroxaban (Xarelto, BAY59-7939) | 137 | Participants | ||
| Number of Participants With Net-clinical Benefit | Antiplatelet | 100 | Participants | ||
| Number of Participants With Cardiovascular Death or Thromboembolic Event | Rivaroxaban (Xarelto, BAY59-7939) | 83 | Participants | ||
| Number of Participants With Cardiovascular Death or Thromboembolic Event | Antiplatelet | 68 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban (Xarelto, BAY59-7939) | 826 | |
| Overall Study | STARTED | Antiplatelet | 818 | |
| Overall Study | Received Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 801 | |
| Overall Study | Received Treatment | Antiplatelet | 807 | |
| Overall Study | COMPLETED | Rivaroxaban (Xarelto, BAY59-7939) | 799 | |
| Overall Study | COMPLETED | Antiplatelet | 792 | |
| Overall Study | NOT COMPLETED | Rivaroxaban (Xarelto, BAY59-7939) | 27 | |
| Overall Study | NOT COMPLETED | Antiplatelet | 26 |
Source ClinicalTrials.gov
Adverse events1,180
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 | Anaemia | Blood and lymphatic system disorders | Rivaroxaban Arm | 10 | 801 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Antiplatelet Arm | 3 | 807 | 3 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Rivaroxaban Arm | 5 | 801 | 5 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Antiplatelet Arm | 0 | 807 | 0 |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Rivaroxaban Arm | 2 | 801 | 2 |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Antiplatelet Arm | 0 | 807 | 0 |
| other | Splenomegaly | Blood and lymphatic system disorders | Rivaroxaban Arm | 2 | 801 | 2 |
| other | Splenomegaly | Blood and lymphatic system disorders | Antiplatelet Arm | 1 | 807 | 1 |
| other | Angina pectoris | Cardiac disorders | Rivaroxaban Arm | 2 | 801 | 2 |
| other | Angina pectoris | Cardiac disorders | Antiplatelet Arm | 4 | 807 | 5 |
1 to 10 of 1,180Source ClinicalTrials.gov
See all 1,180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban Arm | 70 | 801 |
| Total, all-cause mortality | Antiplatelet Arm | 43 | 807 |
| Total, other adverse events | Rivaroxaban Arm | 359 | 801 |
| Total, other adverse events | Antiplatelet Arm | 302 | 807 |
| Total, serious adverse events | Rivaroxaban Arm | 296 | 801 |
| Total, serious adverse events | Antiplatelet Arm | 282 | 807 |
Source ClinicalTrials.gov
Papers5
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With Death or First Thromboembolic Event (DTE) | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With Death or First Thromboembolic Event (DTE) | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With Primary Bleeding Event (PBE) | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With Net-clinical Benefit | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With Cardiovascular Death or Thromboembolic Event | Trial comparisons |
| Rivaroxaban Arm vs Antiplatelet Arm: deaths from any cause | Trial comparisons |
| Rivaroxaban Arm vs Antiplatelet Arm: 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/NCT02556203
GET https://conductscience.org/api/trials/v1/NCT02556203/events?page=2