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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | ISIS CRP Rx followed by Placebo |
|
| Group B | Experimental | Placebo followed by ISIS CRP Rx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISIS CRP Rx | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| AF burden reduction | Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring | 113 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastbourne General Hospital - Cardiology Department | Eastbourne | East Sussex | BN21 2UD | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000601948 | ISIS 329993 |
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|
| 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 | Change from Baseline will be compared for each treatment period | 113 Days |
| To assess the safety of ISIS CRP Rx in subjects with paroxysmal AF | Incidence rates of all Adverse Events will be tabulated by MedRA system Organ Class and by MedRA Term for each treatment group. Lab Tests, Vital Signs, And ECG Parameters will be summarized by study visit for each treatment group. | 113 Days |
| To assess the tolerability of ISIS CRP Rx in subjects with paroxysmal AF | Incidence rates of all Adverse Events will be tabulated by MedRA system Organ Class and by MedRA Term for each treatment group. Lab Tests, Vital Signs, And ECG Parameters will be summarized by study visit for each treatment group. | 113 Days |
| To assess the pharmacokinetics of ISIS CRP Rx in subjects with paroxysmal AF | Trough levels of ISIS CRP Rx will be assessed at intervals throughout the study | 113 Days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |