Phase 4 N=64 Randomized Triple-blind Treatment

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

Stable Angina Pectoris · Atherosclerosis

Bottom Line

View on ClinicalTrials.gov: NCT01363661 ↗

Enrolled (actual)

Serious AEs

28.1%

Results posted

Sep 2014

Primary outcome: Primary: Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12). — 330.60; 164.08 Relative change versus baseline (%)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Coruno (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Therabel Pharma SA/NV
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).	330.60; 164.08	—
SECONDARY Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).	361.98; 326.26	—
SECONDARY Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).	218.07; 96.35; 98.57; 95.13	—
SECONDARY Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).	-40; -40; 0.5; -23; -39; -37	—
SECONDARY Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).	3; 1	—
SECONDARY Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).	57; 79; 7; 12	—

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.

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 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01363661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.