Trial Outcomes & Findings for Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris (NCT NCT01363661)
NCT ID: NCT01363661
Last Updated: 2014-10-06
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
165 participants
Primary outcome timeframe
12 months
Results posted on
2014-10-06
Participant Flow
The drop-out rate post-PCI was high (\>60%) mainly because the Endoscore was frequently above the pre-defined threshold post-PCI, attesting of the absence of endothelial dysfunction. Post-randomization drop-out rate was also high, 25% of patients being lost between randomization and month 12, mainly for non-serious adverse events.
Participant milestones
| Measure |
Molsidomine
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
18
|
28
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
| Measure |
Molsidomine
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris
Baseline characteristics by cohort
| Measure |
Molsidomine
n=18 Participants
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=28 Participants
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 Years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
64.1 Years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
63.5 Years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
18 participants
n=99 Participants
|
28 participants
n=107 Participants
|
46 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Per protocol population
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%.
Outcome measures
| Measure |
Molsidomine
n=18 Participants
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=28 Participants
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).
|
330.60 Relative change versus baseline (%)
Standard Deviation 1014.98
|
164.08 Relative change versus baseline (%)
Standard Deviation 433.41
|
SECONDARY outcome
Timeframe: Month 6Population: Per protocol population
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%.
Outcome measures
| Measure |
Molsidomine
n=18 Participants
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=28 Participants
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).
|
361.98 Relative change versus baseline (%)
Standard Deviation 1248.52
|
326.26 Relative change versus baseline (%)
Standard Deviation 1155.90
|
SECONDARY outcome
Timeframe: Month 6 and Month 12Population: Per protocol population
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%.
Outcome measures
| Measure |
Molsidomine
n=18 Participants
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=28 Participants
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).
Month 6
|
218.07 Relative change versus baseline (%)
Standard Deviation 437.38
|
96.35 Relative change versus baseline (%)
Standard Deviation 323.14
|
|
Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).
Month 12
|
98.57 Relative change versus baseline (%)
Standard Deviation 470.39
|
95.13 Relative change versus baseline (%)
Standard Deviation 290.41
|
SECONDARY outcome
Timeframe: Month 12Population: Per protocol population
Outcome measures
| Measure |
Molsidomine
n=18 Participants
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=28 Participants
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
Endothelial microparticles
|
-40 Relative change versus baseline (%)
Standard Deviation 75
|
-40 Relative change versus baseline (%)
Standard Deviation 42
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
Platelet microparticles
|
0.5 Relative change versus baseline (%)
Standard Deviation 101
|
-23 Relative change versus baseline (%)
Standard Deviation 252
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
Leukocyte microparticles
|
-39 Relative change versus baseline (%)
Standard Deviation 83
|
-37 Relative change versus baseline (%)
Standard Deviation 29
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
sICAM-1
|
-6 Relative change versus baseline (%)
Standard Deviation 51
|
6 Relative change versus baseline (%)
Standard Deviation 47
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
IL-8
|
13 Relative change versus baseline (%)
Standard Deviation 43
|
-25 Relative change versus baseline (%)
Standard Deviation 149
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
hs-CRP
|
-50 Relative change versus baseline (%)
Standard Deviation 237
|
-35 Relative change versus baseline (%)
Standard Deviation 163
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
MOX-LDL
|
11 Relative change versus baseline (%)
Standard Deviation 80
|
41 Relative change versus baseline (%)
Standard Deviation 83
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
MPO antigen
|
-1 Relative change versus baseline (%)
Standard Deviation 19
|
-32 Relative change versus baseline (%)
Standard Deviation 128
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
MPO activity
|
-43 Relative change versus baseline (%)
Standard Deviation 51
|
8 Relative change versus baseline (%)
Standard Deviation 149
|
|
Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).
MPO activity/antigen ratio
|
-42 Relative change versus baseline (%)
Standard Deviation 60
|
7 Relative change versus baseline (%)
Standard Deviation 68
|
SECONDARY outcome
Timeframe: Month 12Population: Intention-to-treat population
Sum of the events collected during 12 months.
Outcome measures
| Measure |
Molsidomine
n=32 Participants
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=32 Participants
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).
|
3 Number of events
|
1 Number of events
|
SECONDARY outcome
Timeframe: Month 12Population: Intention-to-treat population
Sum of the events collected during 12 months.
Outcome measures
| Measure |
Molsidomine
n=32 Participants
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=32 Participants
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).
Non-serious AE
|
57 Number of events
|
79 Number of events
|
|
Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).
SAE
|
7 Number of events
|
12 Number of events
|
Adverse Events
Molsidomine
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Molsidomine
n=32 participants at risk
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=32 participants at risk
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
3.1%
1/32 • Number of events 1 • 1 year
|
0.00%
0/32 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
3.1%
1/32 • Number of events 1 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina unstable
|
6.2%
2/32 • Number of events 2 • 1 year
|
0.00%
0/32 • 1 year
|
|
Cardiac disorders
Arteriogram coronary
|
3.1%
1/32 • Number of events 1 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.1%
1/32 • Number of events 1 • 1 year
|
0.00%
0/32 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.1%
1/32 • Number of events 1 • 1 year
|
0.00%
0/32 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Investigations
Sleep study
|
0.00%
0/32 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Molsidomine
n=32 participants at risk
Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day
|
Placebo
n=32 participants at risk
Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.2%
2/32 • Number of events 2 • 1 year
|
12.5%
4/32 • Number of events 4 • 1 year
|
|
Cardiac disorders
Chest pain
|
6.2%
2/32 • Number of events 2 • 1 year
|
31.2%
10/32 • Number of events 10 • 1 year
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • Number of events 3 • 1 year
|
3.1%
1/32 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
25.0%
8/32 • Number of events 8 • 1 year
|
9.4%
3/32 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
3.1%
1/32 • Number of events 1 • 1 year
|
12.5%
4/32 • Number of events 4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60