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Angina, StablePhase 3ASPIRENCT01550614

Efficacy and Safety of Ad5FGF-4 for Myocardial Ischemia in Patients With Stable Angina Due to Coronary Artery Disease

A Phase 3 study testing Alferminogene tadenovec in people with Angina, Stable, run by Cardium Therapeutics at 1 site in Russia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Angina, Stable
What is being tested?
Alferminogene tadenovec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteRussia
Study dates
Mar 2012to May 2016
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18-75 years of age, inclusive
  • Postmenopausal female patients, women of childbearing potential and men willing to use an effective contraception method while on the study treatment and/or who agree not to become pregnant or make their partner pregnant throughout the study and during one year after administration of the study drug
  • Female subjects of childbearing potential who have a negative urine pregnancy test, and are willing to use an acceptable form of birth control during the study
  • Diagnostic coronary angiogram in the past confirming the presence of coronary artery disease. Patients with extensive disease, or high risk for intervention, or who don't want the higher risk angioplasty or surgery, or have had angioplasty with recurrent angina and vessels are not ideal for angioplasty are ideal candidates
  • Stable angina pectoris being treated with chronic anti-anginal medication(s) at a stable dose for 2 weeks prior to randomization
  • Left ventricular ejection fraction (LVEF) of ≥30%. If the LVEF is <30% the patient can be enrolled if there is no recent or current congestive heart failure present
Show all 9Show fewer
  • Evidence of stress induced myocardial ischemia by ATP technetium-99m sestamibi SPECT, defined as a reversible perfusion defect size of ≥9%
  • Willing and able to comply with the study requirements
  • Provided written informed consent

Who cannot join

  • Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study and one year after administration of the study drug. Women of child bearing potential who are not using an acceptable method of birth control. Women of child bearing potential with a positive urine pregnancy test within 24 hours prior to the start of investigational product
  • Patients with unstable angina for whom an immediate revascularization procedure is indicated
  • Patients for whom a cardiac revascularization procedure is planned in the next 3 months
  • Myocardial infarction within the 3 months prior to the Screening visit
  • Congestive heart failure NYHA Class IV
  • Myocarditis or restrictive pericarditis
Show all 19Show fewer
  • 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)
  • A single patent coronary conduit (for example, totally occluded RCA and LCx with no bypass grafts. Patient will not tolerate balloon occlusion of the LAD for infusion)
  • Clinically significant aortic or mitral valvular heart disease.
  • Life threatening coronary ostial stenosis that precludes adequate catheter engagement in any target vessel, unless the vessel can be accessed via a patent bypass graft
  • Coronary artery to venous communications, which bypass the coronary capillary bed
  • Untreated life-threatening ventricular arrhythmias
  • Uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic pressure >100 mm Hg
  • CABG surgery within the past 6 months, unless those grafts are now occluded
  • Percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months, unless the stented/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 therapy
  • Patients who 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

1 site in 1 country.

Russia1 site

  • Municipal Hospital #15

    Moscow

Other trials in Russia

About this study

Official title: A Randomized, Controlled, Parallel Group, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Ad5FGF-4 Using SPECT Myocardial Perfusion Imaging in Patients With Stable Angina Pectoris

The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8 weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.

Conditions
Angina, Stable
Being tested
Alferminogene tadenovec
Keywords
Angina Pectoris, Myocardial Ischemia, Chest Pain, Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Perfusion, Reversible Perfusion Defect Size, SPECT-MIBI, Anti-Anginal Medication, Quality of Life
Medical subject headings
Angina, Stable, Angina Pectoris, Myocardial Ischemia, Chest Pain, Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases

What participants receive

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

  • Alferminogene tadenovecGenetic

    Also called Generx, Cardionovo (Russian Trade Name)

    One-time intracoronary infusion of Ad5FGF-4 (6x10e9 viral particles in buffer)

Study groups in NCT01550614
Study groupRoleWhat they receive
Arm A: Ad5FGF-4ExperimentalAdenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer and standard of care angina medication
Receives: Genetic: Alferminogene tadenovec
Arm BNo interventionStandard of care angina medication

What is being measured

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

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

    Measured: Baseline and Week 8

Secondary outcomes (5)

  1. Change in angina frequency and nitroglycerin use

    Measured: Baseline and Week 8

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

    Measured: Baseline and Week 8

  3. Change in patient functional class using CCS anginal classification

    Measured: Baseline and Week 8

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

    Measured: Through Week 8

  5. Long-term safety of Ad5FGF-4 as assessed by serious adverse events

    Measured: Through Month 12

Timeline

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

  1. First posted12 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2016

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
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01550614
Sponsor's protocol ID
CT-3-002
Acronym
ASPIRE
Status last verified
Sep 2016
First submitted
29 Feb 2012
Last updated
29 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

  • Grines CL, Watkins MW, Mahmarian JJ, Iskandrian AE, Rade JJ, Marrott P, Pratt C, Kleiman N; Angiogene GENe Therapy (AGENT-2) Study Group. A randomized, double-blind, placebo-controlled trial of Ad5FGF-4 gene therapy and its effect on myocardial perfusion in patients with stable angina. J Am Coll Cardiol. 2003 Oct 15;42(8):1339-47. doi: 10.1016/s0735-1097(03)00988-4.

    PubMed 14563572

  • Grines CL, Watkins MW, Helmer G, Penny W, Brinker J, Marmur JD, West A, Rade JJ, Marrott P, Hammond HK, Engler RL. Angiogenic Gene Therapy (AGENT) trial in patients with stable angina pectoris. Circulation. 2002 Mar 19;105(11):1291-7. doi: 10.1161/hc1102.105595.

    PubMed 11901038

  • Kaski JC, Consuegra-Sanchez L. Evaluation of ASPIRE trial: a Phase III pivotal registration trial, using intracoronary administration of Generx (Ad5FGF4) to treat patients with recurrent angina pectoris. Expert Opin Biol Ther. 2013 Dec;13(12):1749-53. doi: 10.1517/14712598.2013.827656. Epub 2013 Aug 19.

    PubMed 23957658

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alferminogene tadenovec in people with Angina, Stable, run by Cardium Therapeutics at 1 site in Russia.

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 19 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: stopped early, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. 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. 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?

The study was stopped early. 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 reversible perfusion defect size (RPDS) as measured by adenosine triphosphate (ATP) single-photon emission computed tomography with technetium-99m sestamibi (SPECT) (time frame: Baseline and Week 8). 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 NCT01550614, which also lists 4 linked publications.

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 29 Sep 2016.

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