Trial Outcomes & Findings for Lipoprotein Apheresis in Refractory Angina Study (NCT NCT01796912)

Results Overview

Baseline compare to 3 month, changes presented Determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging. Increase means better outcome

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

3 months

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	First Lipoprotein Apheresis, Then Sham Apheresis Three months of weekly lipoprotein apheresis, 1 month of washout then three month of sham apheresis	First Sham Apheresis, Then Lipoprotein Apheresis Three months of weekly sham apheresis, 1 month of washout then three months of weekly lipoprotein apheresis
First Intervention STARTED	10	10
First Intervention COMPLETED	10	10
First Intervention NOT COMPLETED	0	0
Washout STARTED	10	10
Washout COMPLETED	10	10
Washout NOT COMPLETED	0	0
Second Intervention STARTED	10	10
Second Intervention COMPLETED	10	10
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participant n=20 Participants Participant were randomised to undergoing lipoprotein apheresis weekly for three months or sham apheresis weekly for three months with assessment of myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina symptoms and quality of life at the beginning and end of treatment. Patients then crossovered to the opposite study arm with the protocol repeated.
Age, Continuous	60.9 years STANDARD_DEVIATION 9.5 • n=20 Participants
Sex: Female, Male Female	1 Participants n=20 Participants
Sex: Female, Male Male	19 Participants n=20 Participants
Region of Enrollment United Kingdom	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: 3 months

Baseline compare to 3 month, changes presented Determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging. Increase means better outcome

Outcome measures

Outcome measures
Measure	Lipoprotein Apheresis n=20 Participants Three months of weekly lipoprotein apheresis	Sham Apheresis n=20 Participants Three months of weekly sham apheresis
Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging	0.47 ratio Interval 0.31 to 0.63	-0.16 ratio Interval -0.33 to 0.02

SECONDARY outcome

Timeframe: 3 months

Changes from baseline to 3 months

Outcome measures

Outcome measures
Measure	Lipoprotein Apheresis n=20 Participants Three months of weekly lipoprotein apheresis	Sham Apheresis n=20 Participants Three months of weekly sham apheresis
Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging	-335 mm3 Interval -423.0 to -247.0	127 mm3 Interval 72.0 to 183.0

SECONDARY outcome

Timeframe: Within 7 days before and after 3 months of weekly lipoprotein apheresis

EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome

Outcome measures

Outcome measures
Measure	Lipoprotein Apheresis n=20 Participants Three months of weekly lipoprotein apheresis	Sham Apheresis n=20 Participants Three months of weekly sham apheresis
Change in Endothelial Vascular Function	-0.05 index Interval -0.08 to 0.19	-0.03 index Interval -0.18 to 0.11

SECONDARY outcome

Timeframe: 3 months

SAQ-Angina stability, increase means improvement. 0-100 scale, Higher score means improvements

Outcome measures

Outcome measures
Measure	Lipoprotein Apheresis n=20 Participants Three months of weekly lipoprotein apheresis	Sham Apheresis n=20 Participants Three months of weekly sham apheresis
Change in Seattle Angina Questionnaire Score	17.5 units on a scale Interval 6.7 to 28.3	-1.75 units on a scale Interval -17.1 to 9.55

SECONDARY outcome

Timeframe: 3 months

Quality of Life score following, 0-100 score, high score improve quality of life

Outcome measures

Outcome measures
Measure	Lipoprotein Apheresis n=20 Participants Three months of weekly lipoprotein apheresis	Sham Apheresis n=20 Participants Three months of weekly sham apheresis
Change in SF-36 Quality of Life Score	7.5 units on a scale Interval 5.0 to 13.0	-2 units on a scale Interval -4.5 to 1.0

SECONDARY outcome

Timeframe: 3 months

Six minute walk test, patient can walk longer distance means improvements

Outcome measures

Outcome measures
Measure	Lipoprotein Apheresis n=20 Participants Three months of weekly lipoprotein apheresis	Sham Apheresis n=20 Participants Three months of weekly sham apheresis
Change in Exercise Capacity Determined by Six Minute Walk Test	70.5 meter Interval 41.5 to 105.5	3.5 meter Interval -15.1 to 30.8

SECONDARY outcome

Timeframe: 3 months

Thrombogenesis, Reduce value is better to the patients

Outcome measures

Outcome measures
Measure	Lipoprotein Apheresis n=20 Participants Three months of weekly lipoprotein apheresis	Sham Apheresis n=20 Participants Three months of weekly sham apheresis
Changes in Markers of Thrombogenesis	-355 seconds Interval -738.0 to -88.5	36 seconds Interval -56.0 to 204.0

Adverse Events

Lipoprotein Apheresis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Apheresis

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

Dudley Pennell

Imperiwal College London

Phone: +44 (0)20 3811 6871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place