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

Status

Withdrawn

Conditions

Intervention / Treatment

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:

  • 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
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.

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

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.

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