Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris
Condition: Stable Angina Pectoris; Atherosclerosis
MeSH terms: Atherosclerosis; Angina Pectoris; Angina, Stable
Intervention: Coruno; Placebo
Intervention description: Molsidomine 16 mg tablet, per os, once a day; Placebo (16 mg tablet, per os; once-daily)
Intervention MeSH terms: Molsidomine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: angina pectoris; atherosclerosis; endothelial dysfunction

Summary:

      Molsidomine used as an add-on treatment on standard care therapy should be superior to
      placebo used also as an add-on treatment on standard care therapy on improving the
      endothelial function (endothelium score measured by reactive hyperemia - peripheral arterial
      tonometry [RH-PAT]) after 12 months of treatment in patients with stable angina patients and
      undergoing elective percutaneous coronary intervention.

      The study will be double-blind, parallel-group, randomised, multicentre, sequential,
      placebo-controlled study.

      The device used to determine RH-PAT will be EndoPAT. Duration of the treatment = one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years.

          -  No treatment with molsidomine and/or long-acting nitrates (oral or patches) for more
             than 48 hours during the month preceding percutaneous coronary intervention (PCI) and
             no treatment with these same drugs within 3 days before PCI.

          -  Patients who the investigator believes that they and/or their Legally Acceptable
             Representative (LAR) can and will comply with the requirements of the protocol.

          -  Written informed consent from the patient or from the LAR.

          -  Patients who underwent PCI for stable angina pectoris one month prior to the start of
             the study.

          -  Patients presenting endothelial dysfunction at Month 0 (score of the Endo-PAT <0.40).

        Exclusion Criteria:

          -  Pre-menopausal women.

          -  Patient with a clinically-active malignancy.

          -  Known major renal insufficiency or known significant hepatic insufficiency.

          -  History of psychological disorder, mental dysfunction, alcohol or drug abuse or any
             other factor which might interfere with the ability to cooperate in the study.

          -  Participation in another clinical trial which has not yet reached its primary endpoint
             or with the same primary endpoint during the previous month.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject will be exposed to an investigational or a
             non-investigational product (vaccine, drug or device).

          -  Hypersensitivity to molsidomine or to one of its excipients.

          -  Peri-procedural infarction: creatine kinase-muscle/brain (CK-MB) >3 times the upper
             reference limit.

          -  Clinically significant abnormal pre-PCI CK-MB and troponin: any elevation above the
             upper reference limit.

          -  Intolerance to galactose, deficiency in Lapp lactase or glucose-galactose
             malabsorption.

          -  Left ventricular insufficiency (New York Heart Association [NYHA] class III or IV)
             with an ejection fraction <35%.

          -  Acute circulatory insufficiency (e.g. cardiogenic shock).

          -  Hypotension: systolic blood pressure <100 mmHg and/or diastolic blood pressure <70
             mmHg.

          -  Atrial fibrillation

          -  Acute myocardial infarction during the preceding month.

          -  Unsuccessful PCI: residual stenosis of at least 50%.

          -  Patient taking phosphodiesterase-5 inhibitors, such as sildenafil (Viagra®),
             vardenafil (Levitra®) and tadalafil (Cialis®)

          -  Patient taking nebivolol (Nobiten®)

          -  Patient taking ibuprofen + L-arginine as excipient (Spidifen®)

          -  Patient meeting any contraindication(s) from Coruno®. Please refer to Coruno®
             (molsidomine 16 mg o.d.)Summary of Product Characteristics (SPC).