Phase II Study of STA-2 in Patients With Chronic Stable Angina

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01484912
First received: May 9, 2007
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.


Condition Intervention Phase
Chronic Stable Angina
Drug: STA-2
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina

Resource links provided by NLM:


Further study details as provided by Sinphar Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Change in Total Exercise Time [ Time Frame: baseline (visit 2) and week 6 (visit 5) ] [ Designated as safety issue: No ]
    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 Frame: baseline (visit 2) through week 6 (visit 5) ] [ Designated as safety issue: No ]
    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 [ Time Frame: from baseline (visit 2) through week 6 (visit 5) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline (visit 2) to week 6 (visit 5) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline (visit 2) to week 6 (visit 5) ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STA-2

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.

Drug: STA-2

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.

Placebo Comparator: Placebo

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.

Drug: Placebo

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.


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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484912

Locations
Taiwan
Chi Mei Medical Center
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Sinphar Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Chuen-Den Tseng, MD, Ph.D Department of Cardiology National Taiwan University Hospital
  More Information

Publications:
Responsible Party: Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01484912     History of Changes
Other Study ID Numbers: MCCD05014A
Study First Received: May 9, 2007
Results First Received: November 11, 2010
Last Updated: December 1, 2011
Health Authority: Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Sinphar Pharmaceutical Co., Ltd:
Green tea polyphenols
Chronic Stable Angina

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014