Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation

NCT ID: NCT01710852

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-04-30

Brief Summary

The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

ISIS CRP Rx followed by Placebo

Group Type: EXPERIMENTAL

ISIS CRP Rx

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Group B

Placebo followed by ISIS CRP Rx

Group Type: EXPERIMENTAL

ISIS CRP Rx

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

ISIS CRP Rx

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male of female; age over 18 years
• Dual chamber permanent pacemaker implanted
• Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms
• Able to have pacemaker antiarrhythmic algorithms turned off for the duration of the study
• Able to discontinue all Class I and III antiarrhythmic medication for the duration of the study
• Therapeutically anticoagulated with warfarin or dabigatran, and anticipated to be for duration of the study
• High sensitivity C-Reactive Protein (hsCRP) between 2 and 10 mg/L (inclusive)

Exclusion Criteria

• Clinically significant abnormalities in medical history, physical examination, or screening laboratory results that would render a subject unsuitable for inclusion
• NYHA class III/IV heart failure
• Impaired left ventricular function of less than 45% determined by echocardiography within 3 months of screening
• Moderate or greater mitral regurgitation assessed by echocardiography within 3 months of screening
• Permanent AF
• Continuous Amiodarone therapy within 90 days prior to Study Day 1
• Treatment with another Study Drug, biological agent, or device within one-month of screening, or five half-lives of study agent, whichever is longer
• Use of systemic corticosteroids or other anti-inflammatory medications including non-steroidal anti-inflammatory drugs (NSAIDs)
• Use of statins, ACE inhibitors or AT-receptor antagonists unless on a stable regimen for at least 3 months prior to dosing and will remain on a stable regimen for the duration of the study
• Uncontrolled hypertension (BP >160/100)
• Current or expected use of any anticoagulant apart from warfarin or dabigatran

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ionis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eastbourne General Hospital - Cardiology Department

Eastbourne, East Sussex, United Kingdom

Countries

United Kingdom

Other Identifiers

ISIS 329993-CS6

Identifier Type: -

Identifier Source: org_study_id