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Angina PectorisPhase 3AWARENCT00438867

Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization

A Phase 3 study testing Ad5FGF-4 in people with Angina Pectoris, run by Cardium Therapeutics at 47 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether a one-time intracoronary infusion of Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Angina Pectoris
What is being tested?
Ad5FGF-4
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
47 sitesUnited States
Study dates
May 2007to Nov 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients 18-75 years of age inclusive
  • Stable angina classified as CCS III or IV
  • Receiving treatment with at least two classes of chronic anti-anginal medication, of which two are at the maximally tolerated dose
  • Left ventricular ejection fraction (LVEF) of ≥30%
  • Not a candidate for, or unlikely to benefit from standard revascularization procedures as verified by an independent cardiologist or cardiothoracic surgeon (not a study investigator) at each center
  • Can undergo ETT using the modified Bruce protocol and;
Show all 11Show fewer
  • ECG changes diagnostic of myocardial ischemia occur during the first 10 minutes of exercise
  • Variability of the time to onset of ECG changes diagnostic of myocardial ischemia is ≤25% or within 60 seconds if the time to onset of myocardial ischemia occurs within the first 4 minutes of exercise as determined by two consecutive screening treadmill tests
  • Evidence of stress induced myocardial ischemia by adenosine SPECT, defined as a reversible perfusion defect size of ≥9%
  • Willing and able to comply with the study requirements including long-term follow-up
  • Provided written informed consent

Who cannot join

  • Patients of childbearing potential (must be surgically sterile or post-menopausal)
  • Patients for whom an immediate revascularization procedure is indicated (CABG surgery or PCI)
  • Myocardial infarction within the past 3 months
  • Unstable angina or hospitalization requiring intravenous anti-anginal therapy within the 14 days prior to the start of screening evaluations
  • Congestive heart failure NYHA Class IV
  • Electrocardiogram that precludes accurate assessment of exercise induced myocardial ischemia (e.g., left bundle branch block, Wolf-Parkinson-White syndrome, atrial fibrillation)
Show all 35Show fewer
  • Myocarditis or restrictive pericarditis
  • Left main coronary stenosis ≥70% (unless the patient has a patent graft or collateral vessels supplying the left coronary circulation) or proximal stenoses ≥70% in all major coronary conduit vessels (coronary arteries and bypass grafts)
  • Clinically significant aortic or mitral valvular heart disease
  • Coronary ostial stenosis that precludes adequate catheter engagement in any target vessel
  • Coronary artery to venous communications, which bypass the coronary capillary bed
  • Untreated life-threatening ventricular arrhythmias
  • CABG surgery within the past 6 months, unless those grafts are now occluded.
  • Percutaneous transluminal angioplasty (PTCA) within the past 3 months, unless the dilated vessel(s) are now occluded
  • Enhanced external counterpulsation (EECP) within 3 months prior to the start of screening evaluations
  • Transmyocardial or percutaneous myocardial laser revascularization within the previous year
  • Prior treatment with any cardiovascular gene or stem cell therapy.
  • Any intercurrent illness that may interfere with their ability to perform a maximal ETT
  • Any major organ disease that substantially impairs life expectancy.
  • History of cancer, other than basal cell carcinoma, or patients with any laboratory or physical exam or diagnostic procedure finding suggestive of current malignancy
  • Moderate to severe nonproliferative or proliferative retinopathy from any cause (ETDRS score >35), clinically significant macular edema, or previous panretinal photocoagulation therapy
  • Heparin induced thrombocytopenia or history of idiopathic thrombocytopenic purpura or other medical condition causing thrombocytopenia
  • SGPT level greater than 2.0 times the upper limit of the laboratory normal range
  • Bilirubin level ≥2.0 mg/dL
  • Serum creatinine ≥2.5 mg/dL
  • Platelet count <100,000/μL
  • White blood cell count <3,000/μL
  • Positive test for hepatitis B or C
  • Positive test for HIV
  • History of colon cancer in a first degree relative (i.e., parent, sibling or offspring) unless the patient has undergone a colonoscopy in the past 36 months with negative findings
  • History of breast cancer in a first degree relative
  • Patient in a family with any documented hereditary cancer syndrome
  • Prior anaphylaxis reaction to iodinated contrast agents
  • Patients who are known to be immunosuppressed or are receiving chronic treatment with immunosuppressive drugs
  • Received an investigational drug or biologic within 30 days of screening or are currently participating in an investigational drug, biologic or device trial

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • St Joseph's Research Institute

    Atlanta, Georgia, 30342

  • Aurora Denver Cardiology

    Aurora, Colorado, 80012

  • Fox Valley Cardiovascular Consultants

    Aurora, Illinois, 60504

  • Access Clinical Trials

    Beverly Hills, California, 90210

  • University of Alabama

    Birmingham, Alabama, 35294

  • St. Luke's Idaho Cardiology Associates

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Heritage Cardiology Associates

    Camp Hill, Pennsylvania, 17011

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Baylor University Medical Center at Dallas

    Dallas, Texas, 75226

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • St. Mary's Duluth Clinic

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Ohio Heart Center

    Elyria, Ohio, 44035

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana, 46804

  • University of Florida

    Gainesville, Florida, 32610

  • The Stern Cardiovascular Center

    Germantown, Tennessee, 38138

  • The Care Group

    Indianapolis, Indiana, 46290

  • Mid America Heart Institute

    Kansas City, Missouri, 64111

  • BryanLGH Heart Institute

    Lincoln, Nebraska, 68506

  • South Denver Cardiology

    Littleton, Colorado, 80120

  • Midwest Heart Foundation

    Lombard, Illinois, 60148

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Cardiovascular Associates

    Louisville, Kentucky, 40205

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Mission Internal Medical Group

    Mission Viejo, California, 92691

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Lenox Hill Heart & Vascular Institute

    New York, New York, 10021

  • Oklahoma Cardiovascular Associates

    Oklahoma City, Oklahoma, 73109

  • Creighton University

    Omaha, Nebraska, 68131

  • Florida Hospital

    Orlando, Florida, 32803

  • Banner Heart Hospital

    Phoenix, Arizona, 85206

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78229

  • UCSD Medical Center

    San Diego, California, 92103

  • Swedish Medical Center

    Seattle, Washington, 98122

  • St. Anthony's Medical Center

    St Louis, Missouri, 63128

  • Southwest Heart

    Tucson, Arizona, 85715

  • Cardiovascular Associates of East Texas

    Tyler, Texas, 75701

  • Cardiovascular Research Institute

    Washington D.C., District of Columbia, 20010

  • Care Foundation

    Wausau, Wisconsin, 54401

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Female Patients With Stable Angina Pectoris Who Are Not Candidates for Revascularization

The purpose of this study is to determine whether a one-time intracoronary infusion of Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging. Exercise capacity, angina functional class, patient symptoms and quality of life will also be evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.

Conditions
Angina Pectoris
Being tested
Ad5FGF-4, Placebo
Keywords
angina, FGF-4, angiogenesis, growth factor, myocardia ischemia, revascularization
Medical subject headings
Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad5FGF-4Genetic

    Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer

  • PlaceboGenetic

    Control group

Study groups in NCT00438867
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Genetic: Ad5FGF-4
2ExperimentalNot described
Receives: Genetic: Ad5FGF-4
3Placebo comparatorNot described
Receives: Genetic: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT

    Measured: Month 6

Secondary outcomes (10)

  1. Change in reversible perfusion defect size as measured by adenosine single-photon emission computed tomography with technetium-99m sestamibi (SPECT)(principal secondary endpoint)

    Measured: Month 6

  2. Change in total exercise treadmill time

    Measured: Months 3, 6 and 12

  3. Change in time to onset ECG changes diagnostic myocardial ischemia during ETT

    Measured: Months 3 and 12

  4. Change in time to onset of angina during ETT

    Measured: Months 3, 6 and 12

  5. Change in angina frequency and nitroglycerin

    Measured: Months 3 and 6

  6. Change in patient functional status using CCS angina class

    Measured: Months 3, 6 and 12

  7. Change in rest and stress left ventricular ejection fraction assessed using gated SPECT

    Measured: Month 6

  8. Change in quality of life using the Seattle Angina Questionnaire

    Measured: Months 6 and 12

  9. Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing

    Measured: Through month 12

  10. Long-term safety of Ad5FGF-4 as assessed by clinically important events

    Measured: Through month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00438867
Sponsor's protocol ID
CT-3-001
Acronym
AWARE
Status last verified
Nov 2008
First submitted
21 Feb 2007
Last updated
13 Feb 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17825712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ad5FGF-4 in people with Angina Pectoris, run by Cardium Therapeutics at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00438867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.

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