Completed

Lipoprotein Apheresis for Refractory Angina and Elevated Lipoprotein (a)

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What is being tested

Lipoprotein Apheresis

+ Sham Apheresis

Other
Who is being recruted

Cardiovascular Diseases+7

+ Chest Pain

+ Heart Diseases

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorImperial College London
Last updated: November 12, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01796912
Principal SponsorImperial College London
Last updated: November 12, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesChest PainHeart DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaAngina Pectoris

Criteria

5 inclusion criteria required to participate
Hypercholesterolaemia with an elevated Lp(a) > 50mg/dL and an LDL-cholesterol less than 4.0mmol/L despite optimal lipid lowering drug therapy
Patients diagnosed with refractory angina for more than three months
Prescribed optimal medical therapy
Previous history of myocardial infarction, coronary artery bypass graft (CABG) surgery,percutaneous coronary intervention (PCI) or any combination of the above
Show More Criteria
3 exclusion criteria prevent from participating
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
Patients with poor calibre veins for cannulation
Pregnancy, untreated diabetes mellitus, untreated arterial hypertension, and those with general contraindications to undergoing Cardiovascular magnetic resonance imaging or contraindications to adenosine

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Royal Brompton and Harefield NHS Foundation Trust

London, United KingdomOpen Royal Brompton and Harefield NHS Foundation Trust in Google Maps
CompletedOne Study Center