Trial · NCT03702582
Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation
NCT03702582, Phase 3, Completed, Massachusetts General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation. Trials, record NCT03702582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03702582
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation
- NCT number
- NCT03702582
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Interventions
- Rivaroxaban, Warfarin
- First posted
- 2018-10-11
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative Length of Stay | Up to 6 months following the cardiac operation | Length of inpatient stay in days from time of departure from the operating room |
| Secondary | Episode of Major Bleeding (Defined as the Occurrence of Any of Several Events Listed in the Description. No Specific Scale, Questionnaire or Instrument Will be Used) | Up to 30 days after discharge from the initial postoperative hospitalization | Major bleeding defined as re-operation or other therapeutic intervention for bleeding (including but not limited to colonoscopy, upper endoscopy and urologic procedures for hematuria), development of any intracranial bleeding, cessation of study drug for bleeding concerns, reversal of study drug for bleeding concerns and/or new transfusion requirement \> 2 units of blood after drug administration |
| Secondary | Cerebrovascular Accident (CVA) | Up to 30 days after discharge from the initial postoperative hospitalization | Rates of cerebrovascular accident including stroke and transient ischemic attack (TIA) |
| Secondary | Other Systemic Embolism | Up to 30 days after discharge from the initial postoperative hospitalization | Rates of non-neurological systemic arterial embolism involving any organ system |
| Secondary | Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) | Up to 30 days after discharge from the initial postoperative hospitalization | Occurrence of pathologic venous thrombo-embolism including DVT and PE |
| Secondary | Minor Bleeding | Up to 30 days after discharge from the initial postoperative hospitalization | Minor bleeding defined as blood transfusions \<= 2 units or drop in hemoglobin greater 3g/dL following administration of study drugs |
| Secondary | Performance on the EUROQOL (EQ-5D) Quality of Life Instrument | Up to 30 days after discharge from the initial postoperative hospitalization | Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences. |
| Secondary | Performance on the EUROQOL (EQ-5D) Quality of Life Instrument - VAS | Up to 30 days after discharge from the initial postoperative hospitalization | Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences. The visual analog scale is single answer between 0 and 100 representing the patient's perception of their health state. 0 represents the worst health imaginable and 100 represents the best. |
| Secondary | Average Score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) | Up to 30 days after discharge from the initial postoperative hospitalization | Participants will be administered the PACT-Q2 questionnaire which is comprised of a convenience subscale and a satisfaction subscale. For the convenience subscale, each of 13 questions is answered on a 1-5 rating scale with higher numbers representing worse outcomes. A sub-scale score is generated by inverting the score from each element and calculating the sum. Range on the inverted scale is 13 - 65. Higher scores represent better outcomes. For the satisfaction subscale, each of 7 questions is answered on a 1-5 rating scale with higher numbers representing better outcomes. The total score on this subscale is generated by adding up scores from all elements. Range on this subscale is 7-35. Higher scores represent better outcomes. A composite score is generated by adding up scores from both subscales and recalibrating on a 0-100 scale by adding the scores together and applying the formula: COMPOSITE SCORE=100×(Sum-20)/80. Higher scores represent more favorable outcomes. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers12
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/NCT03702582
GET https://conductscience.org/api/trials/v1/NCT03702582/registered