Trial Outcomes & Findings for Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement. (NCT NCT02696226)

Results Overview

Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (\<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (\>70% reduction), or immobile (lack of motion of at least one valve leaflet).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

4-6 weeks post procedure

Results posted on

2018-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	SAVR Warfarin Arm Warfarin arm-(target INR of 2-3) SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely	SAVR Aspirin Arm Aspirin arm (81mg/day) SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care.
Overall Study STARTED	1	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SAVR Warfarin Arm Warfarin arm-(target INR of 2-3) SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely	TAVR Warfarin and Clopidogrel Arm Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely	SAVR Aspirin Arm Aspirin arm (81mg/day) SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care.	TAVR Aspirin and Clopidogrel Arm Aspirin (81mg/day) and Clopidogrel (75mg/day) arm TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely
Overall Study Study terminated - lack of enrollment	1	0	2	0

Baseline Characteristics

Study terminated - lack of enrollment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAVR Warfarin Arm n=1 Participants Warfarin arm-(target INR of 2-3) SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely	TAVR Warfarin and Clopidogrel Arm Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely	SAVR Aspirin Arm n=2 Participants Aspirin arm (81mg/day) SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care.	TAVR Aspirin and Clopidogrel Arm Aspirin (81mg/day) and Clopidogrel (75mg/day) arm TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants • Study terminated - lack of enrollment	0 Participants Study terminated - lack of enrollment	0 Participants n=2 Participants • Study terminated - lack of enrollment	0 Participants Study terminated - lack of enrollment	0 Participants n=3 Participants • Study terminated - lack of enrollment
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants • Study terminated - lack of enrollment	0 Participants Study terminated - lack of enrollment	2 Participants n=2 Participants • Study terminated - lack of enrollment	0 Participants Study terminated - lack of enrollment	2 Participants n=3 Participants • Study terminated - lack of enrollment
Age, Categorical >=65 years	1 Participants n=1 Participants • Study terminated - lack of enrollment	0 Participants Study terminated - lack of enrollment	0 Participants n=2 Participants • Study terminated - lack of enrollment	0 Participants Study terminated - lack of enrollment	1 Participants n=3 Participants • Study terminated - lack of enrollment
Sex: Female, Male Female	0 Participants n=1 Participants • Data was not analyzed due to low enrollment - Study terminated	0 Participants Data was not analyzed due to low enrollment - Study terminated	1 Participants n=2 Participants • Data was not analyzed due to low enrollment - Study terminated	0 Participants Data was not analyzed due to low enrollment - Study terminated	1 Participants n=3 Participants • Data was not analyzed due to low enrollment - Study terminated
Sex: Female, Male Male	1 Participants n=1 Participants • Data was not analyzed due to low enrollment - Study terminated	0 Participants Data was not analyzed due to low enrollment - Study terminated	1 Participants n=2 Participants • Data was not analyzed due to low enrollment - Study terminated	0 Participants Data was not analyzed due to low enrollment - Study terminated	2 Participants n=3 Participants • Data was not analyzed due to low enrollment - Study terminated
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 4-6 weeks post procedure

Population: Study terminated

Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (\<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (\>70% reduction), or immobile (lack of motion of at least one valve leaflet).

Outcome measures

Outcome data not reported

Adverse Events

SAVR Warfarin Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAVR Warfarin and Clopidogrel Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SAVR Aspirin Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAVR Aspirin and Clopidogrel Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Douglas Johnston

Cleveland Clinic

Phone: 216-444-5613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place