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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Change in treadmill exercise duration from baseline
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

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

Cardium Therapeutics

Investigators

  • 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

October 1, 2001

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimate)

June 30, 2006

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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