Clinical trial NCT01363661
Conditions: Stable Angina Pectoris Atherosclerosis
Keywords: angina pectoris atherosclerosis endothelial dysfunction
Sponsor: Therabel Pharma SA/NV
Start date: 2011-06-01; Completion date: 2014-09-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
A Data Steering Committee (DSC) will blindly assess the recruitment rate, the variability of RH-PAT within and between centres, and the safety on a regular basis.

Sequential approach:

* In the first phase (Phase A) of the study, 180 patients will be enrolled in order to get at least 50 completers after 12 months of treatment. A statistical evaluation of the primary endpoint will be done by an Independent Biostatistician after approximately 50 patients have completed the study in accordance with the protocol.
* The results will be examined by an Independent Data Monitoring Committee (IDMC)which will assess the results and advise the sponsor as to:

  1. Continue the study if the primary objective has not been achieved but the difference between the two groups is at least 10% (difference considered clinically significant). In this case, the sample size will be recalculated by the Independent Biostatistician taking into account actual difference and variability. The total number of patients to be enrolled in addition in Phase B will be calculated with precision. Depending on IDMC recommendations, the number of investigating centres will be increased or not for Phase B. If the right number of patients has already been enrolled, Phase B will not start. The study will stop when all enrolled patients have completed the one-year treatment period.
  2. Terminate the study, if the difference between the two groups is less than 10%.
  3. Consider the study as completed if the primary endpoint has been achieved.

Treatment allocation: Balanced allocation between molsidomine and placebo (1:1) with a stratification for consumption of statins, for the type of stent (drug-eluting stent or bare-metal) and for consumption of angiotensin-converting enzyme inhibitors (ACEIs).

Data collection: Electronic Case Report Form (eCRF).

Duration of study: A minimum of 30 months (16 months for inclusion and 14 months for the study) for Phase A.

Number of investigational centres:

* Up to 10 centres for Phase A
* To be determined for Phase B based on Phase A.

Arms: arm 1: Coruno (molsidomine 16 mg tablet; per os; once daily) arm 2: Placebo (16 mg tablet; once a day)
Interventions: intervention 1: Coruno intervention 2: Placebo
Intervention descriptions: intervention 1: Molsidomine 16 mg tablet, per os, once a day intervention 2: Placebo (16 mg tablet, per os; once-daily)

Protocol documents: