Trial Outcomes & Findings for Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow (NCT NCT02254252)
NCT ID: NCT02254252
Last Updated: 2015-03-31
Results Overview
One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
54 participants
Primary outcome timeframe
1 month
Results posted on
2015-03-31
Participant Flow
Participant milestones
| Measure |
Nitroglycerin
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
|
Nicorandil
nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow
Baseline characteristics by cohort
| Measure |
Nitroglycerin
n=24 Participants
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
|
Nicorandil
n=25 Participants
nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthOne month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.
Outcome measures
| Measure |
Nitroglycerin
n=24 Participants
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
|
Nicorandil
n=25 Participants
nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)
|
|---|---|---|
|
Angina Episode Frequnecy
|
2.28 episodes per week
Standard Deviation 0.15
|
1.68 episodes per week
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 1 monthOne month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.
Outcome measures
| Measure |
Nitroglycerin
n=24 Participants
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
|
Nicorandil
n=25 Participants
nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)
|
|---|---|---|
|
Angina Episode Intensity
|
3.89 units on a scale
Standard Deviation 0.30
|
3.03 units on a scale
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: 1 monthOne month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).
Outcome measures
| Measure |
Nitroglycerin
n=24 Participants
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
|
Nicorandil
n=25 Participants
nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)
|
|---|---|---|
|
Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
CCS Class I
|
8 participants
|
19 participants
|
|
Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
CCS Class II
|
11 participants
|
4 participants
|
|
Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
CCS Class III
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 monthPatients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications
Outcome measures
Outcome data not reported
Adverse Events
Nitroglycerin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicorandil
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitroglycerin
n=24 participants at risk
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
|
Nicorandil
n=25 participants at risk
nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
0.00%
0/24
|
4.0%
1/25
|
|
Nervous system disorders
Headache
|
0.00%
0/24
|
12.0%
3/25
|
Additional Information
Pouya Nezafati
Mashhad University of Medical Sciences
Phone: 00989151578421
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place