Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
1 other identifier
interventional
416
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. Two doses will be studied, 2.87 x 10(8) and 2.87 x 10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2001
Longer than P75 for phase_2
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, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 28, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFebruary 9, 2012
November 1, 2008
3.3 years
June 28, 2006
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in treadmill exercise duration from baseline
12 Weeks
Secondary Outcomes (9)
Percentage of patients with a =>30% increase in exercise duration compared to baseline
4 weeks, 12 weeks and 6 months
Number of patients with and time to coronary events or all-cause death
1 Year
Change in treadmill exercise duration compared to baseline
4 weeks and 6 months
Change in time to 1 mm ST segment depression during ETT compared to baseline
4 weeks, 12 weeks and 6 months
Change in time to angina onset during ETT compared to baseline
4 weeks, 12 weeks and 6 months
- +4 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALAd5FGF-4
2
EXPERIMENTALAd5FGF-4
3
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Aged 30-75 years, male or female, with coronary artery disease
- Patients over 50 years of age agree to undergo sigmoidoscopy, unless they have undergone such an exam or colonoscopy within the preceding 36 months with negative findings
- CCS angina Class 2 to 4
- Stable angina for =\>4 weeks despite antianginal drug treatment, and who are able to exercise for at least 3 minutes but no more than 10 minutes on the first qualifying baseline ETT and no more than 12 minutes on the last qualifying baseline ETT using the modified Balke exercise protocol
- LVEF =\>30% by echocardiography, LV angiogram, or a MUGA scan undertaken within the preceding 12 months
- Classic angina or angina equivalent associated with =\>1mm ST segment depression (horizontal or down sloping) at least in the first qualifying ETT. The variability in exercise duration (time to grade 3/4 angina or angina equivalent) does not vary by \> 20% in 2 consecutive tests
- Single, double, or triple vessel coronary artery disease. Patients with 3 vessel disease should have at least 1 proximal major vessel or graft with \<70% stenosis
- Patients who do not require immediate PTCA or CABG surgery
- Provided written informed consent
You may not qualify if:
- Unstable angina
- CCS Class 1 angina
- Patients in whom ECG evidence of exercise induced myocardial ischemia is difficult to detect
- Intercurrent illness which may interfere with the ability to perform the ETT
- Untreated life-threatening ventricular arrhythmias
- Left main coronary artery stenosis =\>70%, unless bypassed with a patent graft
- Coronary artery bypass surgery within the past 6 months, unless those grafts are closed
- In situ arterial CABG other than the RIMA or LIMA, unless it is 100% occluded
- Myocardial infarction within the last 8 weeks
- CHF (NYHA class IV) despite treatment
- Angioplasty within the previous 6 months
- Prior transmyocardial laser revascularization
- Enhanced external counterpulsation (EECP) within 12 weeks prior to study entry
- Coronary ostial stenosis that precludes adequate catheter engagement in any target vessel
- Coronary artery to venous communications which bypass the coronary capillary bed
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24.
PMID: 17825712DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Foster, MD
Cardium Therapeutics, 12255 El Camino Real #250, San Diego, CA 92130, (858) 436-1000
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2006
First Posted
June 30, 2006
Study Start
October 1, 2001
Primary Completion
January 1, 2005
Study Completion
November 1, 2008
Last Updated
February 9, 2012
Record last verified: 2008-11