Randomized, double-blind, placebo-controlled, add-on study in two parallel groups. Patients admitted for Non ST Segment Elevation Acute Coronary Syndromes will undergo a coronary angiography according to the guidelines and, if indicated, an eluting stent implantation. During angiography, a triple-vessel intravascular ultrasonography (IVUS) and virtual histology reconstruction will be performed. MedDRA version: 7.0 Level: HLT Classification code 10011085
Conditions
Interventions
Product Name: CORUNO
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
THERABEL PHARMACEUTICAL Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient who just underwent coronary angiography for NSTE-ACS. - Patient whose ultrasonogram meets predefined quality criteria requirements. - Patient aged = 18 years. - Patient to whom no NO donor, like -long-acting nitrates or molsidomine, was administrated prior to hospitalization. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Female of childbearing age. - Heart failure NYHA III or IV. - Any serious concomitant disorder that could possibly interfere with the clinical evaluation, such as C.O.P.D. or severe anemia. - Active infection or inflammatory process. - Treatment by anti-inflammatory drugs. - Patient with malignancy. - Treatment by drugs for erection disturbances containing phosphodiesterase-5 inhibitors such as sildenafil (Viagra®), vardenafil (Levitra®) and tadalafil (Cialis®). - Known major renal insufficiency (creatinine = 2.0 mg/ml) or known significant hepatic i nsufficiency (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. - Inability to provide informed consent. - Participation in another clinical study during the last previous month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the potential effect of molsidomine 16 mg o.d. on atherosclerosis progression in coronary patients and to seek for a link with the plasma levels in biomarkers of vascular wall inflammation. The primary composite endpoint is to compare atherosclerotic plaque composition under placebo and under molsidomine 16 mg o.d., administered as add-on therapy, in patients hospitalized for NSTE-ACS by using the combined IVUS and VH reconstruction techniques. This analysis will focus on the evolving of lesions in non-culprit segments, in any of the coronary arteries studied at baseline. Primary endpoints will be : - dense calcium, fibrotic plaque, fibrofatty plaque, and necrotic core % of total plaque in at most 4 regions of interest (ROI) - dense calcium, fibrotic plaque, fibrofatty plaque, and necrotic core % of total VH in at most 4 ROI ;Secondary Objective: - to compare total atherosclerotic plaque burden under placebo and under molsidomine 16 mg o.d. by using the combined IVUS, VH and palpography techniques; - to seek for a correlation between the rate of atherosclerosis progression and the levels of hs-CRP, sICAM-1 and other biomarkers at baseline, i.e. at day-1 and /or at visit 1; - to seek for a correlation between the rate of atherosclerosis progression and changes in levels of hs-CRP, sICAM-1, and other biomarkers; - to compare the rate of recurrent cardiac events under placebo and under molsidomine occurring from 1 week post-randomization (cardiac events to be taken into account are recurrent - pectoris, recurrent myocardial infarction unrelated to the treated vessel(s), severe arrhythmia, heart failure, hospitalization for cardiac reason, need for further myocardial revascularization [PTCA, CABG] and cardiac death);;Primary end point(s): The primary composite endpoint is to compare atherosclerotic plaque composition under placebo and under molsidomine 16 mg o.d., administered as add-on therapy, in patients ho | — |
Countries
Belgium
Outcome results
None listed