Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-02-22 @ 4:22 AM
Study NCT ID:
NCT01363661
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris
Sponsor:
Therabel Pharma SA/NV
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDCOR
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-000190-31 | EUDRACT_NUMBER | None | View |