FDA Phase II Clinical Trial of Tasly Danshen Plus

The first IND-approved by FDA

The first that passes FDA’s Phase II Clinical Trial

ObjectiveAssess the efficacy and safety of Tasly Danshen Plus on chronic stable angina pectoris

DesignRandomized, multicenter, double-blind and placebo-controlled clinical trial for the assessment of efficacy and safety of Danshen Plus on chronic stable angina pectoris

Target PopulationModerate chronic stable angina patients aged 18 to 80 and diagnosed with grade-2 or grade-3 angina pursuant to standards of Canadian Cardiovascular Society. Administration of anti-angina drugs and aspirin, statin etc, are stopped during the washout period after 14-day screening while use of one beta receptor antagonist or calcium ion antagonist remains. Only quick acting nitric acid esters can be used for relief in the event of an acute angina.

Flow Chart

Observatory EndpointsPrimary Endpoint:Conduct the board test according to the Bruce program and compare the ETT (Endurance Test Time) differences from the baseline of the treatment group and the placebo control group at trough concentration in the 4th and 8th week.

Secondary Endpoints:

1、 Change in weekly frequency of angina;

2、 Change in the consumption of quick acting nitric acid esters;

3、 Change in time to chest pain during board test in accordance with the Bruce

scale;

4、 Change in the time to 0.1mv ST depression in accordance with the Bruce scale;

5、 Change in quality of life assessment in accordance with the Seattle angina scale;

ResultsChange in total exercise time in exercise endurance test in relation to the baseline (12 hours after medication)

Change in total exercise time in exercise endurance test in relation to the baseline (1-2 hours after medication)

Anti-angina Effect of Danshen Plus with Two Dosing LevelsTED improvement shows obvious dose-effect relation, i.e. bigger dose, more obvious effect. On day 29, the low-dose group and the high-dose group increase by 18s and 44s respectively compared with the placebo group. On day 28 and 29, the differences between high-dose group and placebo group are statistically significant (P<0.05).

Obvious Decline of Weekly Frequency of Angina

（Weekly Frequency of Angina.WFA）

Both the high-dose and low-dose groups, in comparison with the placebo group, have less average frequency of angina and the high-dose group decreases by over 75%.

Obvious Decline of Weekly Nitroglycerin Consumption

（Weekly Frequency of Angina.WFA）

Compared with the placebo group, the treatment group makes great reduction in nitroglycerin administration, average baseline nitroglycerin administration being 0.53 a week.

Improvement of TSTD in Exercise Tolerance Test

(Time to ST Depression, TSTD)

Compared with the placebo group, the high-dose and low-dose groups are comparable in the change of time to ST depression, which indicates that Danshen Plus has good effect of resisting myocardial ischemia.

Improvement of TCP in Exercise Tolerance Test

(Time to Chest Pain, TCP)

Compared with the placebo group, the high-dose and low-dose groups are comparable in the improvement of time to chest pain, which indicates that Danshen Plus has the effect of resisting angina.

Improvement of Quality of Life

(Quality of Life, Qol)

Compared with the placebo group, the high-dose and low-dose groups are comparable in the improvement of patients’ quality of life.

SafetyAdverse reactions of Danshen Plus groups during the trial are mostly trivial and happen less frequently than the placebo group, which shows that they are irrelevant to Danshen Plus.

ConclusionMedication of Tasly Danshen Plus twice a day with 2 and 3 pills each time for 4 and 8 weeks shows marked statistical significance for patients of coronary heart disease-induced stable angina pectoris by great reduction in the usage of nitric acid esters and frequency of angina.

Tasly Danshen Plus is safe and effective for the treatment of stable angina pectoris arising from coronary heart disease.