Lipoprotein Apheresis in Refractory Angina Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-11-30

Brief Summary

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The goal of this study is to determine the impact of apheresis on clinical parameters and symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct a prospective, randomised controlled crossover study of 20 patients with refractory angina and raised Lp(a), 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 will then crossover to the opposite study arm with the protocol repeated. The hypothesis is that the above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and Refractory Angina. Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.

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Detailed Description

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Angina which is refractory to conventional medical therapy and revascularisation is challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no effect on Lp(a) levels.

Conditions

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Refractory Angina Raised Lipoprotein(a)>50mg/dL or >500mg/L

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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First Lipoprotein Apheresis, then sham apheresis

Three months of weekly lipoprotein apheresis, 1 month washout, then three month sham apheresis

Group Type ACTIVE_COMPARATOR

Lipoprotein Apheresis

Intervention Type OTHER

Weekly lipoprotein apheresis for 3 months

First Sham Apheresis, then Lipoprotein Apheresis

Three months of weekly sham apheresis, 1 month washout, then three month lipoprotein Apheresis

Group Type SHAM_COMPARATOR

Sham Apheresis

Intervention Type OTHER

Weekly sham (placebo) apheresis for 3 months

Interventions

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Lipoprotein Apheresis

Weekly lipoprotein apheresis for 3 months

Intervention Type OTHER

Sham Apheresis

Weekly sham (placebo) apheresis for 3 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with refractory angina for more than three months.
* Two or more episodes of angina per week.
* Previous history of myocardial infarction, coronary artery bypass graft (CABG) surgery,percutaneous coronary intervention (PCI) or any combination of the above.
* Prescribed optimal medical therapy.
* Hypercholesterolaemia with an elevated Lp(a) \> 50mg/dL and an LDL-cholesterol less than 4.0mmol/L despite optimal lipid lowering drug therapy.

Exclusion Criteria

* Patients with poor calibre veins for cannulation.
* Patients with any other chronic systemic illness such as liver or renal failure, neoplastic disease, overt cardiac failure, unstable coronary artery disease, coronary revascularisation or a myocardial infarction within the previous eight weeks.
* Pregnancy, untreated diabetes mellitus, untreated arterial hypertension, and those with general contraindications to undergoing Cardiovascular magnetic resonance imaging or contraindications to adenosine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No