Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Therabel Pharma SA/NV
• Treatments: Molsidomine

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).