Trial Outcomes & Findings for IMPROVE AKI Cluster-Randomized Trial (NCT NCT03556293)

NCT ID: NCT03556293

Last Updated: 2025-03-18

Results Overview

Number of Participants with Acute Kidney Injury

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10252 participants

Primary outcome timeframe

within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days

Results posted on

2025-03-18

Participant Flow

Patient procedures were excluded from analysis for one of three reasons: (1) missing post-operation creatinine, (2) history of prior dialysis, or (3) prior eGFR not meeting study eligibility criteria.

Unit of analysis: Hospitals

Participant milestones

Participant milestones
Measure
Technical Assistance (No ASR)
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
Virtual Learning Collaborative (No ASR)
Virtual Learning Collaborative (VLC): The VLC will be offered to 10 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
Technical Assistance With ASR
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard. AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR). Automated Surveillance Reporting (ASR): Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Virtual Learning Collaborative With ASR
Virtual Learning Collaborative (VLC): The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Overall Study
STARTED
2734 5
2967 5
2164 4
2387 5
Overall Study
COMPLETED
830 5
1496 5
1073 4
1118 5
Overall Study
NOT COMPLETED
1904 0
1471 0
1091 0
1269 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Technical Assistance (No ASR)
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
Virtual Learning Collaborative (No ASR)
Virtual Learning Collaborative (VLC): The VLC will be offered to 10 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
Technical Assistance With ASR
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard. AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR). Automated Surveillance Reporting (ASR): Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Virtual Learning Collaborative With ASR
Virtual Learning Collaborative (VLC): The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Overall Study
Ineligible for analysis
1904
1471
1091
1269

Baseline Characteristics

IMPROVE AKI Cluster-Randomized Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Technical Assistance (No ASR)
n=5 Hospitals
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
Virtual Learning Collaborative (No ASR)
n=5 Hospitals
Virtual Learning Collaborative (VLC): The VLC will be offered to 10 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
Technical Assistance With ASR
n=4 Hospitals
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard. AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR). Automated Surveillance Reporting (ASR): Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Virtual Learning Collaborative With ASR
n=5 Hospitals
Virtual Learning Collaborative (VLC): The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Total
n=19 Hospitals
Total of all reporting groups
Age, Continuous
70 Years
n=99 Participants
70 Years
n=107 Participants
70 Years
n=206 Participants
71 Years
n=7 Participants
70 Years
n=31 Participants
Sex: Female, Male
Female
29 Participants
n=99 Participants
56 Participants
n=107 Participants
36 Participants
n=206 Participants
31 Participants
n=7 Participants
152 Participants
n=31 Participants
Sex: Female, Male
Male
801 Participants
n=99 Participants
1440 Participants
n=107 Participants
1037 Participants
n=206 Participants
1087 Participants
n=7 Participants
4365 Participants
n=31 Participants
Race/Ethnicity, Customized
Race · Black
110 Participants
n=99 Participants
371 Participants
n=107 Participants
316 Participants
n=206 Participants
161 Participants
n=7 Participants
958 Participants
n=31 Participants
Race/Ethnicity, Customized
Race · Other
46 Participants
n=99 Participants
72 Participants
n=107 Participants
71 Participants
n=206 Participants
124 Participants
n=7 Participants
313 Participants
n=31 Participants
Race/Ethnicity, Customized
Race · White
674 Participants
n=99 Participants
1053 Participants
n=107 Participants
686 Participants
n=206 Participants
833 Participants
n=7 Participants
3246 Participants
n=31 Participants

PRIMARY outcome

Timeframe: within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days

Number of Participants with Acute Kidney Injury

Outcome measures

Outcome measures
Measure
Technical Assistance (No ASR)
n=830 Participants
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
Virtual Learning Collaborative (No ASR)
n=1496 Participants
Virtual Learning Collaborative (VLC): The VLC will be offered to 10 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
Technical Assistance With ASR
n=1073 Participants
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard. AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR). Automated Surveillance Reporting (ASR): Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Virtual Learning Collaborative With ASR
n=1118 Participants
Virtual Learning Collaborative (VLC): The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Acute Kidney Injury
110 Participants
190 Participants
122 Participants
88 Participants

Adverse Events

Technical Assistance (No ASR)

Serious events: 213 serious events
Other events: 0 other events
Deaths: 2 deaths

Virtual Learning Collaborative (No ASR)

Serious events: 355 serious events
Other events: 0 other events
Deaths: 3 deaths

Technical Assistance With ASR

Serious events: 331 serious events
Other events: 0 other events
Deaths: 1 deaths

Virtual Learning Collaborative With ASR

Serious events: 234 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
Technical Assistance (No ASR)
n=830 participants at risk
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
Virtual Learning Collaborative (No ASR)
n=1496 participants at risk
Virtual Learning Collaborative (VLC): The VLC will be offered to 10 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
Technical Assistance With ASR
n=1073 participants at risk
Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard. AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Technical Assistance (TA): Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR). Automated Surveillance Reporting (ASR): Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Virtual Learning Collaborative With ASR
n=1118 participants at risk
Virtual Learning Collaborative (VLC): The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR). AKI Prevention Toolkit: AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Renal and urinary disorders
New Onset Dialysis
0.36%
3/830 • 18-months
0.40%
6/1496 • 18-months
0.19%
2/1073 • 18-months
0.18%
2/1118 • 18-months
Cardiac disorders
New Heart Failure
9.5%
79/830 • 18-months
10.8%
162/1496 • 18-months
11.8%
127/1073 • 18-months
8.1%
91/1118 • 18-months
Blood and lymphatic system disorders
Bleeding
2.0%
17/830 • 18-months
1.6%
24/1496 • 18-months
4.7%
50/1073 • 18-months
1.8%
20/1118 • 18-months
Vascular disorders
Stroke
0.60%
5/830 • 18-months
0.40%
6/1496 • 18-months
0.84%
9/1073 • 18-months
0.18%
2/1118 • 18-months
Cardiac disorders
Myocardial Infarction
13.1%
109/830 • 18-months
10.5%
157/1496 • 18-months
13.3%
143/1073 • 18-months
10.6%
119/1118 • 18-months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeremiah Brown

Dartmouth College

Phone: (603) 646-5409

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place