Angina PectorisPhase 4SIGMARTNCT01185015
A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization
A Phase 4 study testing Sigmart (nicorandil) in people with Angina Pectoris, run by Merck KGaA, Darmstadt, Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Sigmart (nicorandil)
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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
About this study
Official title: 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.
- Conditions
- Angina Pectoris
- Being tested
- Sigmart (nicorandil)
- Keywords
- Angina Pectoris, Coronary disease
- Medical subject headings
- Angina Pectoris, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigmart (nicorandil)Drug
Also called Sigmart®
Sigmart will be administered for 2 weeks when the subject enters the secondary treatment period (Day 15 to approximately Day 28), at the dosage of 5 mg per oral tid in addition to the previous anti-anginal regimen.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 1 mm ST-depression
It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads
Measured: until day 28
Secondary outcomes (5)
Exercise tolerance test parameters
Exercise Tolerance Test (ETT) parameters include:
- Total exercise time
- Time to onset of chest pain using ETT
- Maximum ST-depression
- SBP × HR (Pressure Rate Product)
- Metabolic Equivalents (METs)
- ETT grade and Score
Measured: until day 28
Consumption of nitroglycerine (NTG).
Weekly assessment of NTG consumption until visit 4 (day 28)
Measured: until day 28
Adverse events
The incidence of adverse events (especially the incidence of headache)
Measured: until day 28
Compliance
Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100)
Measured: until day 28
Number of angina attacks per week
Weekly assessment of angina attacks until day 28
Measured: until day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cherry Ma, PhD, Study director, Beijing Merck Pharmaceutical Consulting Ltd., China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185015
- Sponsor's protocol ID
- 200101-500
- Acronym
- SIGMART
- Status last verified
- Jul 2012
- First submitted
- 18 Aug 2010
- Last updated
- 2 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization
- ClinicalTrials.gov ID
- NCT01185015
- Acronym / sponsor ID
- SIGMART / 200101-500
- Conditions
- Angina Pectoris
- Keywords
- Angina Pectoris, Coronary disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
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 |
|---|---|---|
| Sigmart (nicorandil)Also: Sigmart®Sigmart will be administered for 2 weeks when the subject enters the secondary treatment period (Day 15 to approximately Day 28), at the dosage of 5 mg per oral tid in addition to the previous anti-anginal regimen. | Drug | – |
Primary outcome
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
5 secondary outcomes
Exercise tolerance test parameters
Time frame: until day 28
Consumption of nitroglycerine (NTG).
Time frame: until day 28
Adverse events
Time frame: until day 28
Compliance
Time frame: until day 28
Number of angina attacks per week
Time frame: until day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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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.
Cherry Ma, PhD study director
Beijing Merck Pharmaceutical Consulting Ltd., China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sigmart (nicorandil) in people with Angina Pectoris, run by Merck KGaA, Darmstadt, Germany.
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 22 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: withdrawn, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to 1 mm ST-depression (time frame: until day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2014.