Phase II Study of STA-2 in Patients With Chronic Stable Angina
Condition: Chronic Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Intervention: STA-2; 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 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Green tea polyphenols; Chronic Stable Angina

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.
    

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).