Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation
ASET
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
1 other identifier
interventional
7
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 26, 2015
August 1, 2015
1.5 years
October 9, 2012
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AF burden reduction
Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring
113 Days
Secondary Outcomes (7)
To assess the effect of ISIS CRP Rx on the:
113 Days
To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm
113 Days
To assess the effect of ISIS CRP Rx on measures of Quality of Life
113 Days
To assess whether treatment with ISIS CRP Rx reduces hsCRP in subjects with paroxysmal AF
113 Days
To assess the safety of ISIS CRP Rx in subjects with paroxysmal AF
113 Days
- +2 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALISIS CRP Rx followed by Placebo
Group B
EXPERIMENTALPlacebo followed by ISIS CRP Rx
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastbourne General Hospital - Cardiology Department
Eastbourne, East Sussex, BN21 2UD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 19, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 26, 2015
Record last verified: 2015-08