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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Cardium Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cardium Therapeutics
ClinicalTrials.gov Identifier:
NCT00438867
First received: February 21, 2007
Last updated: February 11, 2013
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Angina Pectoris
Genetic: Ad5FGF-4
Genetic: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cardium Therapeutics:

Primary Outcome Measures:
  • Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in reversible perfusion defect size as measured by adenosine single-photon emission computed tomography with technetium-99m sestamibi (SPECT)(principal secondary endpoint) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change in total exercise treadmill time [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Change in time to onset ECG changes diagnostic myocardial ischemia during ETT [ Time Frame: Months 3 and 12 ] [ Designated as safety issue: No ]
  • Change in time to onset of angina during ETT [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Change in angina frequency and nitroglycerin [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
  • Change in patient functional status using CCS angina class [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Change in rest and stress left ventricular ejection fraction assessed using gated SPECT [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change in quality of life using the Seattle Angina Questionnaire [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: No ]
  • Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing [ Time Frame: Through month 12 ] [ Designated as safety issue: Yes ]
  • Long-term safety of Ad5FGF-4 as assessed by clinically important events [ Time Frame: Through month 60 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: May 2007
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Genetic: Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
Experimental: 2 Genetic: Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
Placebo Comparator: 3 Genetic: Placebo
Control group

  Eligibility

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

Inclusion Criteria:

  • 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;

    1. ECG changes diagnostic of myocardial ischemia occur during the first 10 minutes of exercise
    2. 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

Exclusion Criteria:

  • 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)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438867

  Show 47 Study Locations
Sponsors and Collaborators
Cardium Therapeutics
Investigators
Study Director: Robert Engler, MD Cardium Therapeutics
  More Information

No publications provided by Cardium Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cardium Therapeutics
ClinicalTrials.gov Identifier: NCT00438867     History of Changes
Other Study ID Numbers: CT-3-001
Study First Received: February 21, 2007
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cardium Therapeutics:
angina
FGF-4
angiogenesis
growth factor
myocardia ischemia
revascularization

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014