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Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation (ACT I)

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ClinicalTrials.gov Identifier: NCT00468767
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : April 2, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Vernakalant Injection 20 mg/mL Phase 3

Detailed Description:

There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease & Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.

This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's abilities to convert AF to sinus rhythm. The patient population will include recent onset AF (AF duration of 3 hours to 7 days) and patients with longer AF duration.

This is a double-blind, placebo-controlled, randomized study in patients with AF; stratification will be based on duration of AF. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
Study Start Date : August 2003
Primary Completion Date : November 2004
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Atrial fibrillation (AF) duration of 3 hours to 7 days.
Drug: Vernakalant Injection 20 mg/mL
Other Name: RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)
Experimental: 2
AF duration of >7 days to <45 days
Drug: Vernakalant Injection 20 mg/mL
Other Name: RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)


Outcome Measures

Primary Outcome Measures :
  1. To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm. [ Time Frame: The proportion of patients with atrial fibrillation (AF) of 3 hours to 7 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment. ]

Secondary Outcome Measures :
  1. To assess the safety of RSD1235 in this patient population. [ Time Frame: The proportion of patients with AF of 3 hours to 45 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older;
  • Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days.
  • Have adequate anticoagulant therapy.

Exclusion Criteria:

  • Have a QRS > 0.14 seconds unless patient has pacemaker or uncorrected QT > 0.440 seconds as measured on a 12-lead ECG.
  • Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
  • Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468767


  Show 49 Study Locations
Sponsors and Collaborators
Cardiome Pharma
Astellas Pharma US, Inc.
Investigators
Study Director: Sheila Grant, MBA Cardiome Pharma
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheila Grant, VP of Product Development, Vernakalant, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier: NCT00468767     History of Changes
Other Study ID Numbers: 1235-0703
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008

Keywords provided by Cardiome Pharma:
Atrial fibrillation
RSD1235
Atrial fibrillation of 3 hours to 7 days duration.
Atrial fibrillation of 3 hours to 45 days duration.

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes