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

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo	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.
STA-2	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.

Primary Outcome Measures

Name	Time	Method
Change in Total Exercise Time	baseline (visit 2) and week 6 (visit 5)	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

Name	Time	Method
Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).	baseline (visit 2) through week 6 (visit 5)	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	from baseline (visit 2) through week 6 (visit 5)	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	baseline (visit 2) to week 6 (visit 5)	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	baseline (visit 2) to week 6 (visit 5)	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	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.

Locations (3): National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳
Taipei, Taiwan
Chi Mei Medical Center
🇨🇳
Tainan, Taiwan