Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)

February 8, 2012 updated by: Cardium Therapeutics

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Heparin associated thrombocytopenia (HIT)
  • Moderate to severe nonproliferative or proliferative retinopathy from any cause (ETDRS Score > 35), clinically significant macular edema, or previous panretinal photocoagulation therapy
  • History of malignant neoplasms (except superficial basal cell skin carcinoma) within the past 10 years
  • Malignant tumors or abnormal cancer screening tests suspicious for cancer, or patients in whom screening exams indicate possible occult malignancy, unless malignancy has been ruled out
  • Family history of colon cancer in any first-degree relative, unless the patient has undergone a colonoscopy within the past 12 months with negative findings
  • Elevated PSA level (unless prostate cancer has been excluded)
  • HIV positive
  • Hepatic disease or those who are positive for hepatitis B or C, or whose SGPT is > 2 times the upper limit of normal range, or whose serum bilirubin is > 2 mg/dL.
  • Proteinuria => 2+ unless all other renal parameters are within normal limits.
  • Creatinine clearance < 45 ml/min
  • Platelet count less than 130 x 10(3)/microL
  • WBC count less than 3.0 x 10(3)/microL
  • Patients who are known to be immunosuppressed and/or are receiving chronic immunosuppressive therapy
  • Female patients of childbearing potential. Male patients who do not agree to use birth control (condom) for a period of 8 weeks following study product administration
  • Investigational drug therapy within 30 days of treatment
  • Patients who have received any gene therapy product or angiogenic growth factor protein product
  • Underlying disease(s) other than CAD resulting in a life expectancy of less than 1 year
  • Any clinical abnormality or social circumstance that puts successful completion of the trial in doubt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 3
Placebo
Genetic: Ad5FGF-4 vs. Placebo
Intracoronary infusion
Experimental: 1
Ad5FGF-4
Genetic: Ad5FGF-4 vs. Placebo
Intracoronary infusion
Experimental: 2
Ad5FGF-4
Genetic: Ad5FGF-4 vs. Placebo
Intracoronary infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in treadmill exercise duration from baseline
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients with a =>30% increase in exercise duration compared to baseline
Time Frame: 4 weeks, 12 weeks and 6 months
4 weeks, 12 weeks and 6 months
Number of patients with and time to coronary events or all-cause death
Time Frame: 1 Year
1 Year
Change in treadmill exercise duration compared to baseline
Time Frame: 4 weeks and 6 months
4 weeks and 6 months
Change in time to 1 mm ST segment depression during ETT compared to baseline
Time Frame: 4 weeks, 12 weeks and 6 months
4 weeks, 12 weeks and 6 months
Change in time to angina onset during ETT compared to baseline
Time Frame: 4 weeks, 12 weeks and 6 months
4 weeks, 12 weeks and 6 months
Change in CCS class compared to baseline
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
Change in weekly frequency of anginal attacks compared to baseline
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months
2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months
Change in weekly PRN nitroglycerin use compared to baseline
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months
2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months
Change in quality of life (SAQ, DASI, SF-36, EQ-5D) compared to baseline
Time Frame: 4 weeks, 12 weeks, 6 months and 12 months
4 weeks, 12 weeks, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardium Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paul Foster, MD, Cardium Therapeutics, 12255 El Camino Real #250, San Diego, CA 92130, (858) 436-1000

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 304386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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