Trial · NCT01802775
Edoxaban in Peripheral Arterial Disease
NCT01802775, Phase 2, Completed, Daiichi Sankyo; results first posted 2018-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Edoxaban in Peripheral Arterial Disease. Trials, record NCT01802775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01802775
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Edoxaban in Peripheral Arterial Disease
- NCT number
- NCT01802775
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 203 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Peripheral Arterial Disease
- Interventions
- edoxaban, Clopidogrel, Aspirin
- First posted
- 2013-03-01
- Last updated
- 2019-02-26
- Other registries' IDs
- eudract:2012-003009-88
- Results first posted
- 2018-01-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinically Relevant Bleeding During Treatment | at 3 months | Percentage of participants with clinically relevant bleeding, defined as major bleeding or clinical relevant non-major bleeding, in the on-treatment period based on International Society of Thrombosis and Haemostasis (ISTH) |
| Primary | Percentage of Participants With First Re-stenosis / Re-occlusion | within 6 months | Percentage of participants with re-stenosis/re-occlusion during treatment within 6 months - only the first occurrence of re-stenosis / re-occlusion was counted for each participant |
| Secondary | Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment | within 3 months | The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months |
| Secondary | Safety Assessments | within 6 months | Number of participants with serious adverse events (SAEs) within 6 months Note: Based on changes to the database structure, clinically significant changes in physical or laboratory parameters are recorded as adverse events (AEs). Details of non-serious adverse events are reported at the 5% reporting threshold in the AE module, as is all-cause mortality. |
| Secondary | Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period | within 6 months | Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death |
| Secondary | Number of Participants With Amputations | within 6 months | Number of participants with amputations within 6 months |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinically Relevant Bleeding During Treatment | at 3 months | Safety Analysis Set, defined as all participants who received at least one dose of study drug | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With First Re-stenosis / Re-occlusion | within 6 months | Modified Intent-to-Treat (mITT), defined as all randomized subjects who received at least one dose of the study study and had at least one post-dose duplex scanning | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment | within 3 months | Safety Analysis Set, defined as all participants who received at least one dose of study drug | percentage of participants | NUMBER |
| SECONDARY | Safety Assessments | within 6 months | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period | within 6 months | mITT Set 1 (Safety Analysis Set), defined as the participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Amputations | within 6 months | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinically Relevant Bleeding During Treatment | Clopidogrel | Including Access Site Bleeding (IASB) | 8 | 95% Confidence Interval 3.5 to 15.0 | percentage of participants |
| Percentage of Participants With Clinically Relevant Bleeding During Treatment | Edoxaban | Including Access Site Bleeding (IASB) | 11 | 95% Confidence Interval 5.6 to 18.8 | percentage of participants |
| Percentage of Participants With Clinically Relevant Bleeding During Treatment | Clopidogrel | Excluding Access Site Bleed (EASB) | 6 | 95% Confidence Interval 2.2 to 12.5 | percentage of participants |
| Percentage of Participants With Clinically Relevant Bleeding During Treatment | Edoxaban | Excluding Access Site Bleed (EASB) | 6 | 95% Confidence Interval 2.2 to 12.6 | percentage of participants |
| Percentage of Participants With First Re-stenosis / Re-occlusion | Clopidogrel | 34.7 | percentage of participants | ||
| Percentage of Participants With First Re-stenosis / Re-occlusion | Edoxaban | 30.9 | percentage of participants | ||
| Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment | Clopidogrel | IASB : Major Bleeding | 5 | 95% Confidence Interval 1.6 to 11.2 | percentage of participants |
| Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment | Edoxaban | IASB : Major Bleeding | 1 | 95% Confidence Interval 0 to 5.4 | percentage of participants |
| Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment | Clopidogrel | IASB: CRNM Bleeding | 4 | 95% Confidence Interval 1.1 to 9.8 | percentage of participants |
| Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment | Edoxaban | IASB: CRNM Bleeding | 10 | 95% Confidence Interval 4.9 to 17.6 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clopidogrel | 102 | |
| Overall Study | STARTED | Edoxaban | 101 | |
| Overall Study | Received Drug (Safety Analysis Set) | Clopidogrel | 101 | |
| Overall Study | Received Drug (Safety Analysis Set) | Edoxaban | 100 | |
| Overall Study | COMPLETED | Clopidogrel | 96 | |
| Overall Study | COMPLETED | Edoxaban | 89 | |
| Overall Study | NOT COMPLETED | Clopidogrel | 6 | |
| Overall Study | NOT COMPLETED | Edoxaban | 12 |
Source ClinicalTrials.gov
Adverse events122
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 | Post procedural haematoma | Injury, poisoning and procedural complications | Clopidogrel | 3 | 101 | |
| other | Post procedural haematoma | Injury, poisoning and procedural complications | Edoxaban | 6 | 100 | |
| other | Creatinine renal clearance decreased | Investigations | Clopidogrel | 3 | 101 | |
| other | Creatinine renal clearance decreased | Investigations | Edoxaban | 6 | 100 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Clopidogrel | 7 | 101 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Edoxaban | 7 | 100 | |
| other | Dizziness | Nervous system disorders | Clopidogrel | 1 | 101 | |
| other | Dizziness | Nervous system disorders | Edoxaban | 5 | 100 | |
| other | Headache | Nervous system disorders | Clopidogrel | 0 | 101 | |
| other | Headache | Nervous system disorders | Edoxaban | 5 | 100 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clopidogrel | 0 | 101 |
| Total, all-cause mortality | Edoxaban | 3 | 100 |
| Total, other adverse events | Clopidogrel | 23 | 101 |
| Total, other adverse events | Edoxaban | 32 | 100 |
| Total, serious adverse events | Clopidogrel | 30 | 101 |
| Total, serious adverse events | Edoxaban | 31 | 100 |
Source ClinicalTrials.gov
Papers2
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Clopidogrel vs Edoxaban: Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period | Trial comparisons |
| Clopidogrel vs Edoxaban: Number of Participants With Amputations | Trial comparisons |
| Clopidogrel vs Edoxaban: deaths from any cause | Trial comparisons |
| Clopidogrel vs Edoxaban: Safety Assessments | Trial comparisons |
| Clopidogrel vs Edoxaban: 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/NCT01802775
GET https://conductscience.org/api/trials/v1/NCT01802775/results?page=2