- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01185015
A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization (SIGMART)
July 1, 2014 updated by: Merck KGaA, Darmstadt, Germany
A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization
The multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered Sigmart in subjects with recurrent angina after coronary revascularization.
The primary objective of this study is to demonstrate that orally administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent angina subjects.
Study Overview
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects should be 18~70 years old, male or female
- Subjects should have a history of coronary revascularization at least 6 months ago
- Subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month
- Subjects should be relieved from anginal attacks with short-acting NTG
- Subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study
- Subjects should have an ability to give written informed consent
Exclusion Criteria:
- Unstable angina
- Left main coronary artery disease
- Aortic stenosis
- Obstructive hypertrophic cardiomyopathy
- Subjects with hypertension (SBP>170 mmHg or DBP>100 mmHg) or hypotension (SBP<90 mmHg or DBP<60 mmHg)
- Postural hypotension (drop in systolic blood pressure >20% after 2 minute standing),
- Congestive heart failure (NYHA class III - IV)
- Ejection fraction (EF)<45% by Echocardiography
- Peripheral arterial obstructive disease or other diseases limiting exercise testing
- Arrhythmias requiring active treatment
- Gastro-intestinal ulcer
- Liver dysfunction (defined as ALT or bilirubin>1.5×upper limit of normal value)
- Significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory
- Glaucoma
- Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such as sildenafil, Chinese traditional medicine for treatment of angina pectoris
- Known intolerance to nitrates
- Known allergic to nicotinic acid
- Pregnant or lactating women
- Any other contraindications mentioned in the SPC
- Participation in another clinical study within the last 3 months
- Legal incapacity or limited legal capacity
- Any other subjects assessed by the investigator as being unsuitable for the present study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to 1 mm ST-depression
Time Frame: until day 28
|
It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads
|
until day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise tolerance test parameters
Time Frame: until day 28
|
Exercise Tolerance Test (ETT) parameters include:
|
until day 28
|
Consumption of nitroglycerine (NTG).
Time Frame: until day 28
|
Weekly assessment of NTG consumption until visit 4 (day 28)
|
until day 28
|
Adverse events
Time Frame: until day 28
|
The incidence of adverse events (especially the incidence of headache)
|
until day 28
|
Compliance
Time Frame: until day 28
|
Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100)
|
until day 28
|
Number of angina attacks per week
Time Frame: until day 28
|
Weekly assessment of angina attacks until day 28
|
until day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cherry Ma, PhD, Beijing Merck Pharmaceutical Consulting Ltd., China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
August 18, 2010
First Submitted That Met QC Criteria
August 18, 2010
First Posted (Estimate)
August 19, 2010
Study Record Updates
Last Update Posted (Estimate)
July 2, 2014
Last Update Submitted That Met QC Criteria
July 1, 2014
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200101-500
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Angina Pectoris
-
University Hospital, AntwerpRecruitingAngina Pectoris, Variant | Angina Pectoris; Spasm-Induced | Angina Pectoris With Normal Coronary ArteriogramBelgium
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Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentNot yet recruitingAngina Pectoris; Angiospastic
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Region Örebro CountyBiosensors InternationalWithdrawnStable Angina Pectoris | Unstable Angina Pectoris | Myocardial Infacrtion
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The People's Hospital of Liaoning ProvinceUnknownStable Angina Pectoris | Unstable Angina PectorisChina
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Society for Advancement of Coronary Intervention...UnknownStable Angina Pectoris | Unstable Angina PectorisJapan
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Atlantic Health SystemMallinckrodtTerminatedStable Angina Pectoris | Unstable Angina Pectoris | Silent IschemiaUnited States
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Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Stable Angina PectorisChina
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Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Stable Angina PectorisChina
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Zhejiang Chinese Medical UniversityThe First Affiliated Hospital of Zhejiang Chinese Medical UniversityUnknownChronic Stable Angina PectorisChina
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Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...Unknown
Clinical Trials on Sigmart (nicorandil)
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Zhang Ying QianUnknown
-
Kumamoto UniversityActive, not recruitingCoronary Artery Disease | End Stage Renal DiseaseJapan
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Taipei Medical University WanFang HospitalUnknown
-
Yonsei UniversityGE HealthcareCompleted
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National Cerebral and Cardiovascular CenterCompletedAcute Myocardial InfarctionJapan
-
Peking University Third HospitalCompletedCoronary Artery DiseaseChina
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Ahmed Abdel Nasser Abdel RadyNot yet recruiting
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Fudan UniversityRecruitingST Elevation Myocardial Infarction | Percutaneous Coronary InterventionChina
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Guy's and St Thomas' NHS Foundation TrustActive, not recruitingCritical IllnessUnited Kingdom
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Sejong General HospitalUnknownCoronary Artery Disease | Heart Failure With Reduced Ejection FractionKorea, Republic of