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New treatment option for Refractory Angina
Official title Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
ClinicalTrials.gov ID: NCT07048808
What this study is testing
What is XC001?
XC001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory angina.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD. Part 1 of the study is comprised of 3 subjects with RA (CCS class II-IV) who will receive 4×1011 viral particles (vp) XC001.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Males and females, age 18 to 85 years, inclusive, at the time of signing the ICF.
- Diagnosis of chronic angina due to obstructive CAD that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass...
- Angina class II-IV as measured by CCS Functional Classification of Angina Pectoris.
- History of evidence of reversible left ventricular ischemia, as assessed by stress ECG (including screening), stress echocardiography, single- photon...
- Coronary angiography (and/or computed tomography (coronary) angiography (CTA)) within the past 18 months unless there is a clinical indication to...
You likely can't join if
- Any of the following:
- ST-Elevation or non-ST elevation myocardial infarction (STEMI or NSTEMI) not requiring revascularization, transmural MI, or cerebral vascular...
- Uncontrolled hypercholesterolemia defined as low-density lipoprotein (LDL) above 190 mg/dL.
- Uncontrolled hypertension (systolic blood pressure [BP] \>180 mmHg, diastolic BP \>100 mmHg) despite maximal medical treatment.
- Current untreated malignant ventricular arrhythmias (with episode of sustained or non-sustained ventricular tachycardia (VT) in last 30 days...
- Current untreated bradyarrhythmia (\<50 bpm) for which a new artificial pacemaker placement is anticipated during the study period. A current...
See the full eligibility criteria
Who can join
- Males and females, age 18 to 85 years, inclusive, at the time of signing the ICF.
- Diagnosis of chronic angina due to obstructive CAD that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) (as defined...
- Angina class II-IV as measured by CCS Functional Classification of Angina Pectoris.
- History of evidence of reversible left ventricular ischemia, as assessed by stress ECG (including screening), stress echocardiography, single- photon emission computed tomography (SPECT), CT angiography imaging with...
- Coronary angiography (and/or computed tomography (coronary) angiography (CTA)) within the past 18 months unless there is a clinical indication to warrant a more current procedure as determined by the investigator.
- Two baseline ECG stress tests (treadmill test, modified Bruce protocol) that adhere to the following (details outlined in the ETT manual): i. A modified Bruce protocol that includes two three-minute warm- up stages of...
- On a stable regimen of anti-anginal, anti-hypertensive, and lipid lowering medications deemed medically appropriate for RA at the discretion of the investigator. The chronic anti-anginal regimen must include at least...
- Formally approved by the ERC to undergo the study procedure by a review of past medical history and screening assessments, with emphasis on reversible left ventricular ischemia (further details provided in the ERC...
- All people capable of procreation with their partners must agree to use a highly effective and medically accepted method of contraception for 6 months following the study procedure (Day 1) to avoid pregnancy (as defined...
- Postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to screening. In addition, at least 2 high follicle stimulating hormone (FSH) measurements in the postmenopausal range must...
- Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening
- Female people agree to not donate oocytes and male people must agree not to donate sperm for 6 months following administration of the investigational product (IP).
- Capable of providing informed consent and undergoing all the required tests and procedures in the protocol.
What rules you out
- Any of the following:
- ST-Elevation or non-ST elevation myocardial infarction (STEMI or NSTEMI) not requiring revascularization, transmural MI, or cerebral vascular accident within the past 60 days prior to the screening visit.
- Uncontrolled hypercholesterolemia defined as low-density lipoprotein (LDL) above 190 mg/dL.
- Uncontrolled hypertension (systolic blood pressure [BP] \>180 mmHg, diastolic BP \>100 mmHg) despite maximal medical treatment.
- Current untreated malignant ventricular arrhythmias (with episode of sustained or non-sustained ventricular tachycardia (VT) in last 30 days; suspected/probable/definite).
- Current untreated bradyarrhythmia (\<50 bpm) for which a new artificial pacemaker placement is anticipated during the study period. A current pacemaker is allowed.
- Congestive heart failure defined as New York Heart Association Function Class III or IV or left ventricular ejection fraction \< 25% within the 6 weeks prior to the screening visit (or as assessed by the screening...
- Anginal episodes that routinely require the administration of opiates.
- Moderate to severe aortic valve stenosis (defined as Doppler echocardiography determined peak pressure gradient that exceeds 40 mm Hg (or Vmax \>3.2 m/s) and/or people with a mechanical valve in the aorta valve position.
- Presence of a ventricular thrombus (as defined by contrast transthoracic echocardiography at screening). people may be rescreened after 6 weeks of adequate treatment and absence of ventricular thrombus by...
- Body mass index \> 45 kg/m2.
- Hemoglobin \ 3 x upper limit of normal (ULN), total bilirubin \> 2 x ULN unless the subject has a previously known history of Gilbert's syndrome and estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
- Diabetic with current glycosylated hemoglobin (HbA1c) \> 9.5% or active proliferative diabetic retinopathy.
- Documented active proliferative retinopathy from any cause (ETDRS [Early Treatment Diabetic Retinopathy Study] score \>35).
- Uncontrolled coagulation disorder (that cannot be corrected by pharmacotherapy)
- Patients with unstable chronic obstructive pulmonary disease despite adequate treatment.
- A history or evidence of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV), or active hepatitis B virus (HBV).
- Severely immuno-compromised patients, including high-dose chronic corticosteroid therapy or cytostatic (oncolytic) therapy.
- Diagnosis of, or treatment for, any cancer within the last 5 years except for cutaneous basal or squamous cell carcinoma or carcinomas in situ where surgical excision was considered curative. (Past medical history of...
- Known hypersensitivity or any other contraindication to adenosine, regadenoson, or contrast agents used in any of the radiographic procedures or contraindication to anesthesia employed for the study procedure.
- Pregnancy or currently lactating.
- Receiving an investigational intervention or participating in another clinical trial within 30 days or within 5 half-lives of the drug prior to screening. Exception may be made if the individual is enrolled in a non-...
- Prior participation in any gene therapy; however, if the study was unblinded or documentation otherwise exists that the subject was assigned by chance to the placebo control group and did not receive active gene...
- Known allergy to nickel.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.