Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT01363661
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01363661
Study Brief:
Protocol Section:
NCT01363661