A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization (SIGMART)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01185015
First received: August 18, 2010
Last updated: July 1, 2014
Last verified: July 2012

August 18, 2010
July 1, 2014
January 2011
January 2011   (final data collection date for primary outcome measure)
Time to 1 mm ST-depression [ Time Frame: until day 28 ] [ Designated as safety issue: No ]
It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads
Same as current
Complete list of historical versions of study NCT01185015 on ClinicalTrials.gov Archive Site
  • Exercise tolerance test parameters [ Time Frame: until day 28 ] [ Designated as safety issue: No ]

    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
  • Consumption of nitroglycerine (NTG). [ Time Frame: until day 28 ] [ Designated as safety issue: No ]
    Weekly assessment of NTG consumption until visit 4 (day 28)
  • Adverse events [ Time Frame: until day 28 ] [ Designated as safety issue: Yes ]
    The incidence of adverse events (especially the incidence of headache)
  • Compliance [ Time Frame: until day 28 ] [ Designated as safety issue: No ]
    Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100)
  • Number of angina attacks per week [ Time Frame: until day 28 ] [ Designated as safety issue: No ]
    Weekly assessment of angina attacks until day 28
Same as current
Not Provided
Not Provided
 
A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Angina Pectoris
Drug: Sigmart (nicorandil)
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.
Other Name: Sigmart®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01185015
200101-500
Not Provided
Cherry Ma, Beijing Merck Pharmaceutical Consulting LTD, an affiliate of Merck KGaA, Darmstadt, Germany.
Merck KGaA
Not Provided
Study Director: Cherry Ma, PhD Beijing Merck Pharmaceutical Consulting Ltd., China
Merck KGaA
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP