Double-blind parallel placebo-controlled study to evaluate the effect of Molsidomine on the Endothelial Dysfunction in patients with stable angina pectoris undergoing a percutaneous CORonary intervention. - MEDCOR2011

Therabel Pharmaceuticals Ltd0 个研究点开始时间: 2011年4月8日最近更新: 2014年8月28日

适应症

试验速览

暂无简介。

•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).

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