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Trial Outcomes & Findings for Phase II Study of STA-2 in Patients With Chronic Stable Angina (NCT NCT01484912)

NCT ID: NCT01484912

Last Updated: 2011-12-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

baseline (visit 2) and week 6 (visit 5)

Results posted on

2011-12-06

Participant Flow

First Patient Enrolled: May-10-2007 Last Patient Completed: Jun-17-2008

Patients underwent one-week screening and washout period prior to randomization

Participant milestones

Participant milestones
Measure
STA-2
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Placebo
Placebo capsule, containing non-active ingredients. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Overall Study
STARTED
39
40
Overall Study
COMPLETED
38
39
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
STA-2
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Placebo
Placebo capsule, containing non-active ingredients. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Overall Study
Withdrawal by Subject
1
0
Overall Study
Physician Decision
0
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
STA-2
n=39 Participants
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Placebo
n=40 Participants
Placebo capsule, containing non-active ingredients. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Total
n=79 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
24 Participants
n=5 Participants
24 Participants
n=7 Participants
48 Participants
n=5 Participants
Age, Categorical
>=65 years
15 Participants
n=5 Participants
16 Participants
n=7 Participants
31 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
8 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Male
34 Participants
n=5 Participants
32 Participants
n=7 Participants
66 Participants
n=5 Participants
Region of Enrollment
Taiwan
39 participants
n=5 Participants
40 participants
n=7 Participants
79 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
STA-2
n=38 Participants
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Placebo
n=39 Participants
Placebo capsule, containing non-active ingredients. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Change in Total Exercise Time
450.39 seconds
Standard Deviation 106.7
411.15 seconds
Standard Deviation 118.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
STA-2
n=38 Participants
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Placebo
n=39 Participants
Placebo capsule, containing non-active ingredients. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).
396.76 seconds
Standard Deviation 109
341.69 seconds
Standard Deviation 138.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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.

Population: The data was not available for analysis, because only two patients administered short-acting nitrates

Outcome measures

Outcome data not reported

Adverse Events

STA-2

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Placebo

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
STA-2
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Placebo
Placebo capsule, containing non-active ingredients. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Surgical and medical procedures
Hospitalization
0.00%
0/39
2.5%
1/40 • Number of events 1

Other adverse events

Other adverse events
Measure
STA-2
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Placebo
Placebo capsule, containing non-active ingredients. Two capsules three times daily for 6 weeks, to be administered in a non-fasting state.
Cardiac disorders
Palpitations
5.1%
2/39 • Number of events 2
0.00%
0/40
General disorders
chest pain
5.1%
2/39 • Number of events 2
0.00%
0/40
Gastrointestinal disorders
Abdominal pain upper
5.1%
2/39 • Number of events 2
0.00%
0/40
Psychiatric disorders
Insomnia
5.1%
2/39 • Number of events 2
0.00%
0/40

Additional Information

Justine Tang

Sinphar Pharmaceutical Co., Ltd. Taiwan

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place