Clinical trial NCT01710852: Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
AF
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: AF burden reduction
timeFrame: 113 Days
Secondary outcomes:
measure: To assess the effect of ISIS CRP Rx on the:
timeFrame: 113 Days
measure: To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm
timeFrame: 113 Days
measure: To assess the effect of ISIS CRP Rx on measures of Quality of Life
timeFrame: 113 Days
measure: To assess whether treatment with ISIS CRP Rx reduces hsCRP in subjects with paroxysmal AF
timeFrame: 113 Days
measure: To assess the safety of ISIS CRP Rx in subjects with paroxysmal AF
timeFrame: 113 Days
measure: To assess the tolerability of ISIS CRP Rx in subjects with paroxysmal AF
timeFrame: 113 Days
measure: To assess the pharmacokinetics of ISIS CRP Rx in subjects with paroxysmal AF
timeFrame: 113 Days
Other outcomes:
Locations:
city: Eastbourne
country: United Kingdom
facility: Eastbourne General Hospital - Cardiology Department
state: East Sussex
Study officials:
References: