Last updated on December 2018

A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Microvascular Coronary Artery Disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion criteria:

  • Male or female patient not at childbearing potential 18 year-old or legal age of majority.
  • Female patient if she has undergone sterilization at least 3 months earlier or is post-menopausal.
  • Post-menopausal status is defined by having no menses for 12 months without an alternative medical cause.
  • In females not treated with hormonal replacement therapy (HRT), menopausal status is confirmed by a high follicle stimulating hormone (FSH) level greater than 40 IU/L.
  • In females on HRT and whose menopausal status is in doubt (ie, in women aged less than 45 years), a highly effective contraception methods will be required. Contraception should be used during the whole study and for at least seven days corresponding to time needed to eliminate study treatment.
  • Symptomatic stable angina pectoris (typical or atypical symptoms with an average of at least bi-weekly episodes over the past month).
  • Patients with non-obstructive (<50% stenosis) coronary arteries or intermediate stenosis (between 50 and 70%) should have fractional flow reserve (FFR) >0.80 or instantaneous wave-free ratio (iFR) >0.89 on angiogram, documented within the previous 24 months*. In patients with stenting, a minimum diameter stenosis of <10% is required.

or Coronary computed tomography angiography (CCTA) with finding of non-obstructive coronary arteries within the past 24 months* in patients without previous percutaneous coronary intervention (PCI).

*Note: in cases of clinically suspected progression of atherosclerosis as per the Investigator, a more contemporary (i.e., 6 months) evidence should be provided.

or CCTA performed during screening period, with finding of non-obstructive coronary arteries, in patients diagnosed with microvascular angina (MVA) and stable angina without previous PCI who did not have a coronary angiogram or CCTA in the previous 24 months but between 24 months to 5 years.

  • Baseline global coronary flow reserve (CFR) (measured during the study) assessed by 13N-ammonia or 82Rubidium positron emission tomography (PET) scan <2.0.

Exclusion criteria:

  • Any use of nitrates (except short-acting nitrates) and/or dipyridamole and/or phosphodiesterase type 5 (PDE 5) inhibitors within one week prior to baseline PET scan or anticipated to be used during the study.
  • Esophageal dysmotility or esophagitis.
  • Patients with acute coronary syndrome (ACS) (myocardial infarction [MI] and/or unstable angina) in previous 3 months.
  • Unsuccessful or incomplete coronary revascularization with residual obstructive stenosis or coronary artery disease (CAD) progression in native vessels as documented on invasive coronary angiography (50% stenosis) within 24 months of enrollment.
  • Percutaneous coronary intervention performed at the time of an ACS (MI or unstable angina) in the previous 12 months.
  • Recent PCI within the past 3 months.
  • Patients with history of coronary artery bypass grafting (CABG).
  • Recent (3 months) major surgery (ie, valvular surgery, surgery for congenital heart disease), stroke, transient ischemic attack [TIA], sustained ventricular arrhythmia, clinically significant structural heart disease (moderate-severe valvular disease, hypertrophic cardiomyopathy, congenital heart disease, pulmonary hypertension).
  • Regional local flow abnormal perfusion defects at baseline PET scan*.

*Note: if contemporary evidence with invasive coronary angiography or coronary computed tomography angiography (CCTA) demonstrates non-obstructive coronary arteries or if the regional local flow abnormal perfusion defect on PET scan is consistent with previous studies then patient qualifies for the study.

  • Patients with cardiac conduction abnormalities (second or third degree atrioventricular [AV] block, sick sinus syndrome, symptomatic bradycardia, sinus node disease) except in patients fitted with a functioning pacemaker.
  • History or known carotid stenosis:
  • Carotid stenosis (>50%) or
  • History of carotid stenosis in patients with previous symptoms.
  • Contraindication or known hypersensitivity to adenosine or regadenoson.
  • Contraindication to aminophylline.
  • Contraindication to vasodilator stress PET scan and/or CCTA if CCTA needed during screening.
  • Inability to discontinue treatment with methylxanthines treatment within 24 hours prior to PET scan.
  • Patient unable to read, understand and fill a questionnaire without any help (eg, partially visually impaired or blind).
  • Systolic blood pressure (SBP) <110 mmHg at baseline.
  • Presence at baseline of symptomatic orthostatic hypotension (SBP decrease of 20 mmHg or more at Minute 3 or Minute 5 between seated and standing position), or asymptomatic orthostatic hypotension with a decrease in SBP equal or greater than 30 mmHg at Minute 3 or Minute 5 when changing from the seated to the standing position.
  • Renal impairment with estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 at screening and baseline.
  • Drug-induced liver injury related criteria:
  • Underlying hepatobiliary disease.
  • Alanine Aminotransferase (ALT) >3 times the upper limit of normal (ULN).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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