A study of clinical research intended to estimate the effect of Coruno ® molsidomine, on the dysfunction of the endothelium layer of cells which recover the inside of blood vessels and which plays a role in the dilation and the contraction of vessels as well as in the coagulation of the blood in patients suffering from stable angina pectoris and undergoing a percutaneous coronary intervention.
- Conditions
- Patients with stable angina undergoing elective PCI, used an add-on treatment on standard care therapy, molsidomine or placebo to improve the endothelial function (12 months treatment)MedDRA version: 14.1Level: LLTClassification code 10011079Term: Coronary artery disease NOSSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-000190-31-BE
- Lead Sponsor
- Therabel Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
All patients must satisfy ALL the following criteria at study entry (Visit 1 - Month -1):
•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 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.
All patients must satisfy the following criterion at randomisation (Visit 2 - Month 0):
•Patients who underwent PCI for stable angina pectoris one month prior to the start of the study (30 ? 7 days).
•Patients presenting ED at Month 0 (Endoscore index <0.40) (Rubinshtein et al., 2009).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
•Pre-menopausal women.
•Patient with a clinically-active malignancy.
•Known major renal insufficiency (creatinine ?2.0 mg/ml) or known significant hepatic insufficiency (SGOT ?2 times upper limit, total bilirubin ?1.5 times upper limit).
•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: CK-MB >3 times the upper reference limit (Thygesen et al., 2007).
•Clinically significant abnormal pre-PCI CK-MB and troponin: any elevation above the upper reference limit (Thygesen et al., 2007).
•Intolerance to galactose, deficiency in Lapp lactase or glucose-galactose malabsorption.
•Left ventricular insufficiency (NYHA class III or IV) with an ejection fraction <35%.
•Acute circulatory insufficiency (e.g. cardiogenic shock).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate in stable angina patients undergoing elective PCI the superiority of molsidomine, used as an add-on treatment on standard care therapy, over placebo on improving the endothelial function (Endoscore measured by RH-PAT) after 12 months of treatment.;Secondary Objective: To estimate the effect of molsidomine and placebo on the augmentation index (an index of arterial stiffness) as measured by RH-PAT.<br>To determine the impact of molsidomine on the following endothelial biomarkers: <br>?hs-CRP<br>?sICAM-1<br>?IL-8<br>?Myeloperoxidase (in terms of concentration and activity)<br>?Myeloperoxidase oxidized-LDL (MOx-LDL)<br>?Isoprostanes<br>?Microparticles from the endothelium, leukocytes and platelets<br>To compare the rate of serious cardiovascular events (SCEs) in the two groups.<br>;Primary end point(s): Change versus baseline in the Endoscore index in the two groups after one year of treatment (Month 12).;Timepoint(s) of evaluation of this end point: Month 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Change versus baseline in the Endoscore index in the two groups after six months of treatment (Month 6).<br>•Change versus baseline in the augmentation index in the two groups after six and twelve months of treatment (Months 6 and 12).<br>•Change versus baseline in the endothelial biomarkers (see Secondary objectives section) after six and twelve months of treatment (Months 6 and 12).<br>•Frequency of serious cardiovascular events (SCEs) in the two groups after six and twelve months of treatment (Months 6 and 12).<br>•Frequency of AEs and SAEs in the two groups after six and twelve months of treatment (Months 6 and 12).<br>;Timepoint(s) of evaluation of this end point: Month 6 and Month 12