Trial · NCT02293395
A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
NCT02293395, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2017-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome. Trials, record NCT02293395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02293395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
- NCT number
- NCT02293395
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3,037 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Acute Coronary Syndrome
- Interventions
- Acetylsalicylic acid, Rivaroxaban, Clopidogrel, Ticagrelor
- First posted
- 2014-11-18
- Last updated
- 2017-12-26
- Other registries' IDs
- eudract:2014-004266-26
- Results first posted
- 2017-11-13
- Limitations and caveats
Study population was homogenous with limited participation of non-Caucasian participants. Randomization was not performed for use of P2Y12 inhibitor; strata comparisons between bleeding and efficacy endpoints are confounded and were not planned.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events | From start of study treatment until follow-up (up to 390 days) | Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (\>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of \>=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - \<5 g/dl (or drop in hematocrit of 9 - \<15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event. |
Source ClinicalTrials.gov
Outcomes1
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 Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events | From start of study treatment until follow-up (up to 390 days) | Population analyzed included all randomized participants who had received at least one dose of study agent and had events that occurred between randomization and the last dose of the study agent plus 2 days or untreated participants who had events that occurred between randomization to 2 days thereafter. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
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 Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events | Rivaroxaban 2.5 mg Twice Daily (BID) | 80 | participants | ||
| Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events | Acetylsalicylic Acid 100 mg Once Daily (OD) | 74 | participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban 2.5 mg Twice Daily (BID) | 1,519 | |
| Overall Study | STARTED | Acetylsalicylic Acid 100 mg Once Daily (OD) | 1,518 | |
| Overall Study | Treated | Rivaroxaban 2.5 mg Twice Daily (BID) | 1,510 | |
| Overall Study | Treated | Acetylsalicylic Acid 100 mg Once Daily (OD) | 1,506 | |
| Overall Study | COMPLETED | Rivaroxaban 2.5 mg Twice Daily (BID) | 1,510 | |
| Overall Study | COMPLETED | Acetylsalicylic Acid 100 mg Once Daily (OD) | 1,511 | |
| Overall Study | NOT COMPLETED | Rivaroxaban 2.5 mg Twice Daily (BID) | 9 | |
| Overall Study | NOT COMPLETED | Acetylsalicylic Acid 100 mg Once Daily (OD) | 7 |
Source ClinicalTrials.gov
Adverse events352
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 | Chest Pain | General disorders | Rivaroxaban 2.5 mg Twice Daily (BID) | 11 | 1,510 | |
| other | Chest Pain | General disorders | Acetylsalicylic Acid 100 mg Once Daily (OD) | 19 | 1,506 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Rivaroxaban 2.5 mg Twice Daily (BID) | 16 | 1,510 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Acetylsalicylic Acid 100 mg Once Daily (OD) | 14 | 1,506 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Rivaroxaban 2.5 mg Twice Daily (BID) | 33 | 1,510 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Acetylsalicylic Acid 100 mg Once Daily (OD) | 39 | 1,506 | |
| other | Hypertension | Vascular disorders | Rivaroxaban 2.5 mg Twice Daily (BID) | 23 | 1,510 | |
| other | Hypertension | Vascular disorders | Acetylsalicylic Acid 100 mg Once Daily (OD) | 22 | 1,506 | |
| serious | Anaemia | Blood and lymphatic system disorders | Rivaroxaban 2.5 mg Twice Daily (BID) | 1 | 1,510 | |
| serious | Anaemia | Blood and lymphatic system disorders | Acetylsalicylic Acid 100 mg Once Daily (OD) | 0 | 1,506 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban 2.5 mg Twice Daily (BID) | ||
| Total, all-cause mortality | Acetylsalicylic Acid 100 mg Once Daily (OD) | ||
| Total, other adverse events | Rivaroxaban 2.5 mg Twice Daily (BID) | 81 | 1,510 |
| Total, other adverse events | Acetylsalicylic Acid 100 mg Once Daily (OD) | 84 | 1,506 |
| Total, serious adverse events | Rivaroxaban 2.5 mg Twice Daily (BID) | 125 | 1,510 |
| Total, serious adverse events | Acetylsalicylic Acid 100 mg Once Daily (OD) | 138 | 1,506 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|
Rivaroxaban 2.5 mg Twice Daily (BID) vs Acetylsalicylic Acid 100 mg Once Daily (OD): Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events | Trial comparisons |
| Rivaroxaban 2.5 mg Twice Daily (BID) vs Acetylsalicylic Acid 100 mg Once Daily (OD): 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/NCT02293395
GET https://conductscience.org/api/trials/v1/NCT02293395/events?page=2