AzTrials
AzTrials

Angina PectorisPhase 2/3NCT00346437

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

A Phase 2/3 study of Angina Pectoris, run by Cardium Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Angina Pectoris
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
No sites listed yet
Study dates
Oct 2001to Nov 2008
Phase
Phase 2/3
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • 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

About this study

Official title: 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.

Conditions
Angina Pectoris
Being tested
Ad5FGF-4 vs. Placebo
Keywords
angina, FGF-4, angiogenesis, adenovector, growth factor, myocardial ischemia, revascularization
Medical subject headings
Angina Pectoris, Myocardial Ischemia

What participants receive

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

  • Ad5FGF-4 vs. PlaceboGenetic

    Intracoronary infusion

Study groups in NCT00346437
Study groupRoleWhat they receive
1ExperimentalAd5FGF-4
Receives: Genetic: Ad5FGF-4 vs. Placebo
2ExperimentalAd5FGF-4
Receives: Genetic: Ad5FGF-4 vs. Placebo
3Placebo comparatorPlacebo
Receives: Genetic: Ad5FGF-4 vs. Placebo

What is being measured

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

  1. Change in treadmill exercise duration from baseline

    Measured: 12 Weeks

Secondary outcomes (9)

  1. Percentage of patients with a =>30% increase in exercise duration compared to baseline

    Measured: 4 weeks, 12 weeks and 6 months

  2. Number of patients with and time to coronary events or all-cause death

    Measured: 1 Year

  3. Change in treadmill exercise duration compared to baseline

    Measured: 4 weeks and 6 months

  4. Change in time to 1 mm ST segment depression during ETT compared to baseline

    Measured: 4 weeks, 12 weeks and 6 months

  5. Change in time to angina onset during ETT compared to baseline

    Measured: 4 weeks, 12 weeks and 6 months

  6. Change in CCS class compared to baseline

    Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months

  7. Change in weekly frequency of anginal attacks compared to baseline

    Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months

  8. Change in weekly PRN nitroglycerin use compared to baseline

    Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months

  9. Change in quality of life (SAQ, DASI, SF-36, EQ-5D) compared to baseline

    Measured: 4 weeks, 12 weeks, 6 months and 12 months

Timeline

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

  1. First posted30 Jun 2006 (estimated)
  2. Study startOct 2001
  3. Primary completionJan 2005
  4. Study completionNov 2008

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00346437
Sponsor's protocol ID
304386
Status last verified
Nov 2008
First submitted
28 Jun 2006
Last updated
9 Feb 2012
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 2/3 study of Angina Pectoris, run by Cardium Therapeutics.

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 9 inclusion and 33 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: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 treadmill exercise duration from baseline (time frame: 12 Weeks). 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 NCT00346437, 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 9 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in