329993-CS6, Original

• Research type

  Research Study

• Full title

  A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients with Paroxysmal Atrial Fibrillation: The ASET study

• IRAS ID

  104053

• Contact name

  Neil Sulke

• Eudract number

  2012-000833-38

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  ASET is a Phase 2 study to assess the antiarrhythmic and symptomatic effect of ISIS 329993 in patients with paroxysmal Atrial Fibrillation (AF), a type of intermittent irregular heart beat. ISIS 329993 is an experimental drug that has been shown in other studies to temporarily lower the levels of a protein in the blood called C-reactive protein (CRP). Inflammation in AF is closely related to the production of CRP. Reducing CRP levels may help to reduce AF frequency. The purpose of the ASET study is to determine whether ISIS 329993 will affect the amount of AF (AF burden) patients get. We will also determine whether ISIS 329993 safely and effectively lowers CRP in people with AF, as well as how it affects other aspects of AF, and people??s overall quality of life. Only people with pacemakers will be invited to join the study, because we want to use the pacemakers to determine how much AF people have. This study will be conducted only at Eastbourne District General Hospital and will last up to 22 weeks (about 5« months) for approximately 20 participating patients. During that time, patients will need to visit the study clinic 17 times and will undergo medical exams, questionnaires about their Quality of Life, blood and urine sample collections, and administration of the study drug. ISIS 329993 will be given as via injections under the skin (subcutaneous injection). In this study, the drug is given six times over four weeks. To prevent unfair bias, participants will also get a course of placebo injections. Neither the participants nor the medical staff giving the injections will know which treatment they are using until after all study treatment is completed.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  12/LO/0717

• Date of REC Opinion

  19 Jun 2012

• REC opinion

  Further Information Favourable Opinion