Stable Angina PectorisPhase 4MEDCORNCT01363661
Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris
A Phase 4 study testing Coruno in people with Stable Angina Pectoris and Atherosclerosis, run by Therabel Pharma SA/NV at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina Pectoris, Atherosclerosis
- What is being tested?
- Coruno
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2011to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <0.40).
Who cannot join
- Pre-menopausal women.
- Patient with a clinically-active malignancy.
- Known major renal insufficiency or known significant hepatic insufficiency.
- 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).
Show all 20Show fewer
- Hypersensitivity to molsidomine or to one of its excipients.
- Peri-procedural infarction: creatine kinase-muscle/brain (CK-MB) >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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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.
- Terminate the study, if the difference between the two groups is less than 10%.
- 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.
- Conditions
- Stable Angina Pectoris, Atherosclerosis
- Being tested
- Coruno, Placebo
- Keywords
- angina pectoris, atherosclerosis, endothelial dysfunction
- Medical subject headings
- Angina, Stable, Atherosclerosis, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorunoDrug
Also called Molsidomine
Molsidomine 16 mg tablet, per os, once a day
PlaceboDrug
Placebo (16 mg tablet, per os; once-daily)
| Study group | Role | What they receive |
|---|---|---|
| Molsidomine | Experimental | Coruno (molsidomine 16 mg tablet; per os; once daily) Receives: Drug: Coruno |
| Placebo | Placebo comparator | Placebo (16 mg tablet; once a day) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).
The results are expressed mean relative change (%) between month 12 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 12. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -275% and the maximum observed was +4200%.
Measured: 12 months
Secondary outcomes (5)
Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).
The results are expressed mean relative change (%) between month 6 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 6. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -200% and the maximum observed was +6100%.
Measured: Month 6
Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).
The results are expressed mean relative change (%) between month 6 or month 12, and baseline. A positive result means improvement in the augmentation index between baseline and month 6 or month 12. It could be considered as a surrogate of a decrease of the arterial stiffness. A negative percentage means the inverse. The are no fixed limits to the scale. At month 6,the minimum observed was -139% and the maximum observed was +1600%.At month 12, the minimum observed was -524% and the maximum observed was +1600%.
Measured: Month 6 and Month 12
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
Measured: Month 12
Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).
Sum of the events collected during 12 months.
Measured: Month 12
Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).
Sum of the events collected during 12 months.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therabel Pharma SA/NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuele Barbato, MD, Principal investigator, Cardiology Center, Onze Lieve Vrouw Ziekenhuis Aalst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363661
- Sponsor's protocol ID
- MEDCOR 2011
- Other IDs
- 2011-000190-31
- Acronym
- MEDCOR
- Status last verified
- Sep 2014
- First submitted
- 1 Apr 2011
- Last updated
- 6 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Barbato E, Herman A, Benit E, Janssens L, Lalmand J, Hoffer E, Chenu P, Guedes A, Missault L, Pirenne B, Cardinal F, Vercauteren S, Wijns W. Double-blind parallel placebo-controlled study to evaluate the effect of molsidomine on the endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: the MEDCOR Trial. J Cardiovasc Transl Res. 2014 Mar;7(2):226-31. doi: 10.1007/s12265-013-9513-9. Epub 2013 Oct 19.
PubMed 24142804Barbato E, Herman A, Benit E, Janssens L, Lalmand J, Hoffer E, Chenu P, Guedes A, Missault L, Pirenne B, Cardinal F, Vercauteren S, Wijns W. Long-term effect of molsidomine, a direct nitric oxide donor, as an add-on treatment, on endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: results of the MEDCOR trial. Atherosclerosis. 2015 Jun;240(2):351-4. doi: 10.1016/j.atherosclerosis.2015.03.045. Epub 2015 Apr 7.
PubMed 25875387
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01363661
- Acronym / sponsor ID
- MEDCOR / MEDCOR 2011
- Conditions
- Stable Angina Pectoris, Atherosclerosis
- Keywords
- angina pectoris, atherosclerosis, endothelial dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Therabel Pharma SA/NVIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Posted 26 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Terminate the study, if the difference between the two groups is less than 10%.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molsidomine | Experimental | Drug: CorunoCoruno (molsidomine 16 mg tablet; per os; once daily) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (16 mg tablet; once a day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- Pre-menopausal women.
- Patient with a clinically-active malignancy.
- Known major renal insufficiency or known significant hepatic insufficiency.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorunoAlso: MolsidomineMolsidomine 16 mg tablet, per os, once a day | Drug | Molsidomine |
| PlaceboPlacebo (16 mg tablet, per os; once-daily) | Drug | Placebo |
Primary outcome
Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).
Time frame: 12 months
The results are expressed mean relative change (%) between month 12 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 12. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -275% and the maximum observed was +4200%.
5 secondary outcomes
Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).
Time frame: Month 6
Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).
Time frame: Month 6 and Month 12
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
Time frame: Month 12
Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).
Time frame: Month 12
Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24142804Barbato E, Herman A, Benit E, Janssens L, Lalmand J, Hoffer E, Chenu P, Guedes A, Missault L, Pirenne B, Cardinal F, Vercauteren S, Wijns W. Double-blind parallel placebo-controlled study to evaluate the effect of molsidomine on the endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: the MEDCOR Trial. J Cardiovasc Transl Res. 2014 Mar;7(2):226-31. doi: 10.1007/s12265-013-9513-9. Epub 2013 Oct 19.
- Derived from this study: PubMed 25875387Barbato E, Herman A, Benit E, Janssens L, Lalmand J, Hoffer E, Chenu P, Guedes A, Missault L, Pirenne B, Cardinal F, Vercauteren S, Wijns W. Long-term effect of molsidomine, a direct nitric oxide donor, as an add-on treatment, on endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: results of the MEDCOR trial. Atherosclerosis. 2015 Jun;240(2):351-4. doi: 10.1016/j.atherosclerosis.2015.03.045. Epub 2015 Apr 7.
Related trials for Stable Angina Pectoris
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuele Barbato, MD principal investigator
Cardiology Center, Onze Lieve Vrouw Ziekenhuis Aalst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coruno in people with Stable Angina Pectoris and Atherosclerosis, run by Therabel Pharma SA/NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01363661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.