anginal

The primary objective of this study is to confirm the safety and efficacy of T89 in patients with chronic stable angina pectoris.

Dantonic®

dansan

tablet

75

Primary Objective
The primary objective of this study is to confirm the safety and efficacy of
T89 in patients with chronic stable angina pectoris.
Secondary Objectives
To explore the contribution of Danshen with Borneol to the overall efficacy
of T89.
Exploratory Objective
To compare the safety and efficacy profiles of T89 produced from different
manufacture batches.

Design ：Double blind, randomized, multi-nation, multi-center, placebo controlled, 4
parallel groups with treatment product from different production batches.

Inclusion Criteria
1. Written informed consent.
2. Males and females between the ages of 20 and 80 years.
3. Females of childbearing potential must have a negative pregnancy test,
not be breast feeding and established on a method of contraception that in
the investigator’s opinion is acceptable. Females must agree to remain on
their established method of contraception through their participation in
the study and for 14 days following the last dose of study drug.
4. Evidence of coronary artery disease that consists of a well-documented
medical history (over 3 months prior to the enrolment) of myocardial
infarction or significant coronary artery disease with noninvasive or
angiographic confirmation.
5. Symptoms that support the diagnosis of chronic angina and/or a history of
an abnormal exercise response limited by angina and/or
electrocardiograph (ECG) changes.
6. Moderate angina pectoris (Class II or III, Grading of Angina Pectoris by
the Canadian Cardiovascular Society Classification System).
7. Patient whose symptom-limited Total Exercise Duration (TED) is
between 3 to 7 minutes in Exercise Tolerance Test (ETT) on Standard Bruce Protocol, and symptom-limited TED on two screen examinations
(Day -7 and 0) in which the shorter is within 85% of the longer*.
8. Patient has been on one beta-blocker or one calcium-channel blocker for
at least 14 days prior to dosing of study medication and can remain this
treatment throughout the study as background anti-anginal treatment.
Short-acting nitroglycerin for on-demand use is allowed for all eligible
patients.
9. Understand and be willing, able and likely to comply with all study
procedures and restrictions and comprehends the verbal rating scales and
diary cards.

Exclusion Criteria
1. With contraindication, unable to, or with other co-morbidities that may
prevent or interfere with the ability to perform treadmill ETT (e.g.,
pulmonary hypertension, COPD (chronic obstructive pulmonary disease),
chronic bronchitis, history of pulmonary tuberculosis, prior
hospitalization for acute exacerbation of chronic lung disease or home
oxygen use, chronic oral steroid therapy that can limit exercise capacity,
peripheral artery disease, etc.).
2. Presence of electrocardiographic or other abnormalities/factors that could
interfere with exercise electrocardiograph interpretation or may lead to a
false positive stress test (e.g., pre-exercise horizontal or down-sloping ST
segment depression in any standard lead, cardiac glycoside therapy,
Lown-Ganong-Levine Syndrome, Wolff-Parkinson-White syndrome
(WPW), left bundle branch block, left ventricular hypertrophy with
repolarization abnormality, implanted pacemaker, etc.).
3. Clinically significant arrhythmias or atrioventricular conduction block
greater than first degree, decompensated heart failure, atrial fibrillation,
hypertrophic cardiomyopathy.
4. Acute coronary syndrome in the prior 2 months or coronary
revascularization within the prior 6 months or planned coronary
revascularization during the study period.
5. Congenital cardiac defects, ongoing history of congestive heart failure,
unstable angina, severe valvular disease, severe uncontrolled hypertension
(seated systolic blood pressure > 180 mm Hg or diastolic blood pressure >
110 mm Hg), severe anemia, suspected or known dissecting aneurysm,
acute myocarditis or pericarditis, thrombophlebitis or pulmonary
embolism or recent myocardial infarction within three months of study
entry.
6. History of bleeding diathesis, cerebral hemorrhage, or seizure disorders
that required anticonvulsant medication.
7. Patients requiring the use of long-acting nitroglycerin, ranolazine, and/or
multiple anti-anginal drugs.
8. Aspirin and/or statins started less than 14 days prior to the signing of
informed consent.
9. Pregnancy or lactation.
10. Clinical trials/experimental medication
1) Participation in any other clinical trial or receipt of an investigational
drug within 30 days prior to the initial visit.
2) Previous participation in the studies of T89.
11. Substance abuse. Patients with a recent history (within the last 2 years) of
alcoholism or known drug dependence.
12. Is a family member or relative of the study site staff.
13. Any other conditions that, in the opinion of the investigator, are likely to
prevent compliance with the study protocol or pose a safety concern if the
subject participates in the study.