Clinical trial NCT01185015: A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization
Official title: A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Angina Pectoris
Keywords: Angina Pectoris, Coronary disease
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to 1 mm ST-depression
timeFrame: until day 28
Secondary outcomes:
measure: Exercise tolerance test parameters
timeFrame: until day 28
measure: Consumption of nitroglycerine (NTG).
timeFrame: until day 28
measure: Adverse events
timeFrame: until day 28
measure: Compliance
timeFrame: until day 28
measure: Number of angina attacks per week
timeFrame: until day 28
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Merck Pharmaceutical Consulting Ltd., China
name: Cherry Ma, PhD
role: STUDY_DIRECTOR
References: