Back to resultsPhase II Study of STA-2 in Patients With Chronic Stable Angina
Primary Purpose
Chronic Stable Angina
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
STA-2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stable Angina focused on measuring Green tea polyphenols, Chronic Stable Angina
Eligibility Criteria
Inclusion criteria:
- Male or female aged > 20;
- Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening;
- Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (Day -7);
- Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by >20% in total exercise time;
Female patient who was in the post-menopausal stage or of childbearing potential who:
- used adequate contraception since last menstruation and no plan for conception during the study;
- was non-lactating;
- had negative pregnancy test (urine) within 14 days prior to the study;
- Able to provide written informed consent.
Exclusion criteria:
- Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
- Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator;
- Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);
- Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;
- Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) > 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine > 3 mg/dL);
- Patients with severe gastrointestinal illness as judged by the investigator;
- Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).
Sites / Locations
- Chi Mei Medical Center
- National Taiwan University Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
STA-2
Placebo
Arm Description
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.
Placebo capsule, containing non-active ingredients. Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.
Outcomes
Primary Outcome Measures
Change in Total Exercise Time
Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.
Secondary Outcome Measures
Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).
Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.
Change in Consumption of Short-acting Nitrates
The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.
Change in Rate-pressure Product
Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.
Change in Pharmacological Parameters
The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.
Consumption of Short-acting Nitrates
Full Information
NCT ID
NCT01484912
First Posted
May 9, 2007
Last Updated
December 1, 2011
Sponsor
Sinphar Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01484912
Brief Title
Phase II Study of STA-2 in Patients With Chronic Stable Angina
Official Title
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinphar Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.
Detailed Description
The primary objective of this study was to evaluate the efficacy of STA-2 in the management of chronic stable angina. The secondary objectives of this study were to evaluate the safety and pharmacological activities of STA-2 in the management of chronic stable angina. This was a multi-center, double-blind, randomized, parallel-group, placebo-controlled study of STA-2 in the management of chronic stable angina. The study period for each patient was approximately 7 weeks, during which the patient undergone one-week screening and washout period, followed by 6 weeks of treatment. Each patient was required to make a total of 5 visits. Primary Efficacy Endpoint: Change in total exercise time.
After washout, patients who met the inclusion and exclusion criteria were randomly assigned either to the treatment or control group. The respective regimens were:
Treatment group:
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules ter in die (t.i.d.=three times daily) for 6 weeks, to be administered in a non-fasting state.
Control group:
Placebo 250 mg capsule, 2 capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina
Keywords
Green tea polyphenols, Chronic Stable Angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STA-2
Arm Type
Experimental
Arm Description
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, containing non-active ingredients.
Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.
Intervention Type
Drug
Intervention Name(s)
STA-2
Intervention Description
After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of STA-2 was:
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of Placebo was:
Placebo 250 mg capsule, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.
Primary Outcome Measure Information:
Title
Change in Total Exercise Time
Description
Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.
Time Frame
baseline (visit 2) and week 6 (visit 5)
Secondary Outcome Measure Information:
Title
Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).
Description
Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.
Time Frame
baseline (visit 2) through week 6 (visit 5)
Title
Change in Consumption of Short-acting Nitrates
Description
The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.
Time Frame
from baseline (visit 2) through week 6 (visit 5)
Title
Change in Rate-pressure Product
Description
Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.
Time Frame
baseline (visit 2) to week 6 (visit 5)
Title
Change in Pharmacological Parameters
Description
The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.
Time Frame
baseline (visit 2) to week 6 (visit 5)
Title
Consumption of Short-acting Nitrates
Time Frame
The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Male or female aged > 20;
Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening;
Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (Day -7);
Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by >20% in total exercise time;
Female patient who was in the post-menopausal stage or of childbearing potential who:
used adequate contraception since last menstruation and no plan for conception during the study;
was non-lactating;
had negative pregnancy test (urine) within 14 days prior to the study;
Able to provide written informed consent.
Exclusion criteria:
Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator;
Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);
Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;
Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) > 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine > 3 mg/dL);
Patients with severe gastrointestinal illness as judged by the investigator;
Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuen-Den Tseng, MD, Ph.D
Organizational Affiliation
Department of Cardiology National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chi Mei Medical Center
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
15946418
Citation
Unno T, Tago M, Suzuki Y, Nozawa A, Sagesaka YM, Kakuda T, Egawa K, Kondo K. Effect of tea catechins on postprandial plasma lipid responses in human subjects. Br J Nutr. 2005 Apr;93(4):543-7. doi: 10.1079/bjn20041379.
Results Reference
background
PubMed Identifier
12824094
Citation
Maron DJ, Lu GP, Cai NS, Wu ZG, Li YH, Chen H, Zhu JQ, Jin XJ, Wouters BC, Zhao J. Cholesterol-lowering effect of a theaflavin-enriched green tea extract: a randomized controlled trial. Arch Intern Med. 2003 Jun 23;163(12):1448-53. doi: 10.1001/archinte.163.12.1448.
Results Reference
background
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Phase II Study of STA-2 in Patients With Chronic Stable Angina
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