Atrial Fibrillation Clinical Trial
Official title:
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
| Verified date | September 2011 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common
supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic
therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm
(normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.
Azimilide may have an effect on increasing the time to first recurrence of symptomatic
atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular
tachycardia (other types of abnormal heart rhythms).
This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety
of azimilide compared with placebo in prolonging the time to the first symptomatic
arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart
failure and/or ischemic heart disease) and those without these conditions. Once this phase
of the study is completed, a second phase with a different study design will be conducted.
The second phase is an open-label, follow-up phase. The follow-up phase of the study is
designed to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in
patients who complete the double-blind, placebo-controlled phase of this study.
| Status | Completed |
| Enrollment | 431 |
| Est. completion date | January 2004 |
| Est. primary completion date | January 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities - History of congestive heart failure and/or ischemic heart disease - Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study - At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm. - Sinus rhythm immediately prior to dosing Exclusion criteria: - Previously unsuccessful cardioversions within 60 days of screening period - Failed to respond to any Class III antiarrhythmic drugs - Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization - Previously in an azimilide study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Heart Health Institute | Calgary | Alberta |
| Canada | Heart Health Research Center | Calgary | Alberta |
| Canada | University of Calgary | Calgary | Alberta |
| Canada | Hamilton Health Science Corp. | Hamilton | Ontario |
| Canada | Cardiac Investigation Unit | London | Ontario |
| Canada | Chum Hotel Dieu | Montreal | Quebec |
| Canada | Hospital Sacre-Soeur de Montreal | Montreal | Quebec |
| Canada | Montreal Heart Institute | Montreal | Quebec |
| Canada | Recharche Cardiologie | Montreal | Quebec |
| Canada | Niagara Health System Greater Niagara General Hospital | Niagara Falls | Ontario |
| Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
| Canada | Quebec Heart Institute | Sainte-Foy | Quebec |
| Canada | Neureka Research Corporation | Sudbury | Ontario |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | Cardiology Research St. Paul's Hospital | Vancouver | British Columbia |
| United States | VA Medical Center Therapeutic Section | :Minneapolis | Minnesota |
| United States | Heart Care Group PC | Allentown | Pennsylvania |
| United States | Aurora Denver Cardiology | Aurora | Colorado |
| United States | Tri-State Medical Group Cardiology | Beaver | Pennsylvania |
| United States | Beloit Clinic, SC | Beloit | Wisconsin |
| United States | Cardiovascular Assoc. PC | Birmingham | Alabama |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Cardiovascular Associates of Penisula | Burlingame | California |
| United States | Capitol Interventional Cardiology | Carmichael | California |
| United States | Charleston Cardiology | Charleston | South Carolina |
| United States | MedSource, Inc | Chesapeake | Virginia |
| United States | Mount Sinal Hospital Medical Center | Chicago | Illinois |
| United States | Lindner Clinical Trial Ctr. | Cincinnati | Ohio |
| United States | University Hospitals of Cleveland | Cleveland | Ohio |
| United States | MidWest Cardiology Research Foundation | Columbus | Ohio |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Cardiology Consultants | Daytona Beach | Florida |
| United States | VA Medical Center | Decatur | Georgia |
| United States | Western Cardiology Assoc. | Denver | Colorado |
| United States | Regional Heart Center | Duluth | Minnesota |
| United States | Duke Medical Center | Durham | North Carolina |
| United States | Elgin Cardiology Associates | Elgin | Illinois |
| United States | C/O Research Office Attn: Cardiovascular Research Dept. | Fort Lauderdale | Florida |
| United States | VA Central California Health Care System | Fresno | California |
| United States | Valley Research | Fresno | California |
| United States | SW Florida Heart Group/Health Park Medical Center | Ft. Myers | Florida |
| United States | Heart Center Medical Group | Ft. Wayne | Indiana |
| United States | Altru Health System Research Center | Grand Forks | North Dakota |
| United States | Internal Medical Associates | Grand Island | Nebraska |
| United States | Grass Valley Cardiology | Grass Valley | California |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Fairview Range Regional Health Services | Hibbing | Minnesota |
| United States | Hillsboro Cardiology | Hillsboro | Oregon |
| United States | Cardiovascular Institute of the South | Houma | Louisiana |
| United States | Methodist Hospital | Houston | Texas |
| United States | The Care Group | Indianapolis | Indiana |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Dean/Riverview Clinic | Janesville | Wisconsin |
| United States | The Pavillion | Jenkintown | Pennsylvania |
| United States | San Diego Cardiovascular Associates | La Jolla | California |
| United States | Richard Gilmore, MD 501 S Ryan Street | Lake Charles | Louisiana |
| United States | Watson Clinic, LLP | Lakeland | Florida |
| United States | Thoracic & Cardiovascular Healthcare Foundation | Lansing | Michigan |
| United States | University of Arkansas Medical Center | Little Rock | Arkansas |
| United States | Cardiology Section, West Los Angeles VA Hospital | Los Angeles | California |
| United States | Good Samaritan Hospital | Los Angeles | California |
| United States | LAC+USC Medical Center | Los Angeles | California |
| United States | Louisville Cardiology Medical Group, P.S.C | Louisville | Kentucky |
| United States | University of Louisville-Cardiology | Louisville | Kentucky |
| United States | University of Wisconsin Madison | Madison | Wisconsin |
| United States | Marshfield Clinic | Marshfield | Wisconsin |
| United States | Stern Cardiovascular Center Research Department | Memphis | Tennessee |
| United States | Merced Heart Associates | Merced | California |
| United States | Khalid Hassan Sheikh 80 Fontenberry Road | Merritt Island | Florida |
| United States | St. Patrick Hosp/Western Mt. Clinic Cardiology | Missoula | Montana |
| United States | The Heart Group, PC | Mobile | Alabama |
| United States | Sutter Gould Medical Foundation | Modesto | California |
| United States | Cardiovascular of the South | Morgan City | Louisiana |
| United States | Cardiovascular Institute of the South | New Iberia | Louisiana |
| United States | Tulane University | New Orleans | Louisiana |
| United States | Riverside Regional Medical Center | Newport News | Virginia |
| United States | Illinois Heart & Lung Research Center, SC | Normal | Illinois |
| United States | Oklahoma Foundation for Cardiovascular Research | Oklahoma City | Oklahoma |
| United States | Florida Cardiology | Orlando | Florida |
| United States | Cardiology Research Assiocates | Ormond Beach | Florida |
| United States | The Center for Advanced Cardiology | Park Ridge | Illinois |
| United States | Nisus Research | Petoskey | Michigan |
| United States | UPHS/Presbyterian Medical Center | Philadelphia | Pennsylvania |
| United States | Cardiovascular and Critical Care Associates, P.C. | Pittsburgh | Pennsylvania |
| United States | Maine Medical Center | Portland | Maine |
| United States | Oregon Health Sciences University | Portland | Oregon |
| United States | ARI Clinical Trials | Redondo Beach | California |
| United States | William Olney, MD 21 Whitehall Rd, Suite 200 | Rochester | New Hampshire |
| United States | Regional Cardiology Assoc. | Sacramento | California |
| United States | Sacramento Heart and Vascular Medical Associates | Sacramento | California |
| United States | Heart and Vascular Inst. of Texas, PA | San Antonio | Texas |
| United States | Cardiology Associates | San Diego | California |
| United States | Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401 | Seattle | Washington |
| United States | Medical Research Institute | Slidell | Louisiana |
| United States | Cardiovascular Institute of the South | Thibodaux | Louisiana |
| United States | Riverside Osteopathic Hospital | Trenton | Michigan |
| United States | Southern Arizona VA Health Care System, Section of Cardiology (1-111C) | Tucson | Arizona |
| United States | University Medical Center | Tucson | Arizona |
| United States | The George Washington University MFA | Washington | District of Columbia |
| United States | Professional Research Network of Kansas | Wichita | Kansas |
| United States | Cardiology & Int. Medicine | Williamsville | New York |
| United States | University of Massachusett | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To prolong the tachycardia-free period in patients | 6 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
| Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
| Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
| Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
| Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
| Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
| Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
| Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
| Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
| Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
| Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
| Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
| Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
| Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
| Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
| Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
| Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
| Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
| Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |