Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
Completed · Phase 1/Phase 2
Conditions studied: Coronary Artery Disease, Ischemia, Angina Refractory, Cardiovascular Diseases, Heart Diseases
In brief
The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).
Key facts
- Study ID
- NCT04125732
- Run by
- XyloCor Therapeutics, Inc.
- People needed
- 41
- Starts
- 2020-01-24
- Expected to finish
- 2023-05-30
- Last updated by the study team
- 2024-01-30
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females, age 18 to 80 years
- Diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention
- Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris
- Adequate hematologic (hemoglobin ≥ 10 g/dL, absolute neutrophil count > 1.2 × 10\^3 per μL and platelet count ≥ 75,000 per μL), hepatic (alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN; total bilirubin ≤ 2 x ULN), and renal function (glomerular filtration rate > 29 mL/minute/1.73 m2)
- Adequate birth control if of child-bearing potential
- Must be willing and able to provide informed consent
You may not qualify if…
- ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days
- New York Heart Association Function Class III or IV or left ventricular ejection fraction < 25% within the 6 weeks prior to the screening visit
- HbA1c ≥ 8.5%, SBP <90 or >180 mmHg, DBP >100 mmHg
- Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study
Where it is running
- Stanford University — Stanford, California, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Cardiology Research Associates — Daytona Beach, Florida, United States
- University of Florida — Gainesville, Florida, United States
- James A. Haley VA Medical Center — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
- Duke University — Durham, North Carolina, United States
- The Christ Hospital / The Lindner Research Center — Cincinnati, Ohio, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- The Ohio State University — Columbus, Ohio, United States
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States
- Houston Methodist — Houston, Texas, United States
- Texas Heart Institute — Houston, Texas, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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