Clinical trial NCT01484912: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Stable Angina
Keywords: Green tea polyphenols
Chronic Stable Angina
Lead sponsor: Sinphar Pharmaceutical Co., Ltd
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. Male or female aged \> 20;
2. 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;
3. 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);
4. 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;
5. 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;
6. Able to provide written informed consent.

Exclusion criteria:

1. Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
2. 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;
3. Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);
4. Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;
5. 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);
6. Patients with severe gastrointestinal illness as judged by the investigator;
7. Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).

Primary outcomes:
measure: Change in Total Exercise Time
timeFrame: baseline (visit 2) and week 6 (visit 5)
Secondary outcomes:
measure: Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).
timeFrame: baseline (visit 2) through week 6 (visit 5)
measure: Change in Consumption of Short-acting Nitrates
timeFrame: from baseline (visit 2) through week 6 (visit 5)
measure: Change in Rate-pressure Product
timeFrame: baseline (visit 2) to week 6 (visit 5)
measure: Change in Pharmacological Parameters
timeFrame: baseline (visit 2) to week 6 (visit 5)
measure: Consumption of Short-acting Nitrates
timeFrame: 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.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Department of Cardiology National Taiwan University Hospital
name: Chuen-Den Tseng, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.