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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Cardium Therapeutics
Sponsor:
Collaborator:
Advanced Biosciences Research
Information provided by (Responsible Party):
Cardium Therapeutics
ClinicalTrials.gov Identifier:
NCT01550614
First received: February 29, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Angina, Stable
Genetic: Alferminogene tadenovec
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cardium Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in angina frequency and nitroglycerin use [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Change in quality of life using the Seattle Angina Questionnaire [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Change in patient functional class using CCS anginal classification [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing [ Time Frame: Through Week 8 ] [ Designated as safety issue: Yes ]
  • Long-term safety of Ad5FGF-4 as assessed by serious adverse events [ Time Frame: Through Month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer and standard of care angina medication
Genetic: Alferminogene tadenovec
One-time intracoronary infusion of Ad5FGF-4 (6x10e9 viral particles in buffer)
Other Names:
  • Generx
  • Cardionovo (Russian Trade Name)
No Intervention: Arm B
Standard of care angina medication

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550614

Locations
Russian Federation
Municipal Hospital #15 Recruiting
Moscow, Russian Federation
Contact: Ivan Gordeev, DMed    +7495 918 72 84    cardio-15@yandex.ru   
Principal Investigator: Ivan Gordeev, DMed         
Sponsors and Collaborators
Cardium Therapeutics
Advanced Biosciences Research
Investigators
Study Director: Gabor Rubanyi Cardium Therapeutics
  More Information

Publications:
Responsible Party: Cardium Therapeutics
ClinicalTrials.gov Identifier: NCT01550614     History of Changes
Other Study ID Numbers: CT-3-002
Study First Received: February 29, 2012
Last Updated: June 4, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Cardium Therapeutics:
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014