Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients With Stable Angina

Inclusion Criteria:

1. Willing to participate and sign a written informed consent

2. Males and females ≥ 18 and ≤90 years old.

3. Medical history of chronic stable angina triggered by physical effort and relievedby rest or sublingual nitroglycerin.

4. Patients who agree and in the opinion of the investigator are able to withdraw allnon-beta blocker and all non-calcium channel blocker anti-anginal medications. Forthose subjects who are on beta blockers and/or calcium channel blockers, they areable to keep only one beta blocker or one calcium channel blocker (acceptablecalcium channel blocker: amlodipine, diltiazem, verapamil or nicardipine), but notboth, and subjects agree and are expected to be able to remain on this treatmentregimen from Day -21 until the completion of the double-blind period in the opinionof the investigator.

4.1) For patients who have to modify their anti-anginal treatment regimen to meetthe above qualification criteria, health care provider who is responsible for thepatient's cardiac care (if this is not the study doctor) must provide a form ofagreement (verbal conversation, phone call, in writing or shown as referral) to thePI before the treatment modification.

4.2) For patients who are not on beta blocker or calcium channel blocker or otherantianginal medications, there is no requirement to start on antianginal medication.

*nitroglycerin tablets, only those provided by sponsor, are allowed to be used foron-demand symptomatic relief of angina during the qualifying and treatment periodsto ensure an accurate calculation of consumption.

5. Documented history of coronary artery disease with one or more of the followingconditions:

5.1) History of previous myocardial infarction (previous MI that occurred and wasdiagnosed at least 3 months prior to start of screening).

5.2) Ischemic heart disease determined by stress myocardial imaging examination (including nuclear stress test, cardiac stress MRI and echocardiography stresstest).

5.3) Clinically significant coronary stenosis ≥50% in any vessel detected bycoronary angiography (or coronary CT angiography).

6. Understand and be willing, able and likely to comply with all study procedures andrestrictions and comprehends the Seattle Angina Questionnaire rating scales anddiary cards.

7. Women of child bearing potential: Female patients of child-bearing potential or malepatients with partners of child-bearing potential must use appropriate birth controlfrom the start of screening, until 3 months after the last dose of study medication.Female patients of child bearing potential must have negative pregnancy tests atscreening visit [Day -21, quantitative serum human chorionic gonadotropin (β-hCGtest)] and randomization visit (Day 1, urine pregnancy test).

8. Patient must experience two or more angina episodes from Day-14 to Day 1, as thebaseline frequency of angina. At least two of the angina episodes must be recordedby WCM (Other written forms of recording/reporting angina episodes may be acceptableonly in situations and times that recording by WCM is impractical. In addition,patients are allowed to use short acting nitroglycerin for relief of angina).

9. To be qualified, patients must have two qualifying ETTs on standard Bruce protocolon Day- 7 and Day 1. The qualifying ETTs are:

10. ETTs must meet the positive ETT criteria;

11. Total exercise duration (TED) of the positive ETT is between 3-12 minutes ofexercise;

12. The difference in TED between the two ETTs must not exceed 15% of the longerone.

• For the qualifying ETTs, in patients with permitted baseline ST-segmentdepression at rest (<1 mm at 80 msec after the J point), qualifyingST-segment depression during ETT will be defined as additional ST-segmentdepression ≥1 mm (at 80 msec after the J point) below the resting value.

Exclusion Criteria:

1. Patients with only non-cardiac chest pain or cardiac chest pain not related toangina.

2. Patients with contraindication to, unable to, or with other co-morbidities that mayprevent or interfere with the ability to perform ETT, in the opinion ofinvestigator, including but not limited to: hospitalization for acute exacerbationof chronic lung disease within 4 weeks prior to the start of screening, current homeoxygen use, needs for cardiac glycoside therapy, functionally limiting peripheralarterial disease, physical disability or other intercurrent illness such as acuterespiratory infection/illness that, in the opinion of the Investigator orSub-investigator, may interfere with the ability to perform ETT.

3. Patients with presence of electrographic or other abnormalities/factors that couldinterfere with exercise ECG interpretation or may lead to a false positive stresstest (including but not limited to, Lown-Ganong-Levine Syndrome (LGL),Wolff-Parkinson-White Syndrome (WPW), left bundle branch block, ≥1 mm ST segmentdepression at rest, pacemaker rhythm etc.).

*Left ventricular hypertrophy (LVH) without repolarization abnormalities is notconsidered an exclusion criterion.

4. Patients with history of any coronary revascularization procedure (e.g. PCI or CABG)within 2 months prior to the start of screening.

5. Patients who had unstable angina, or myocardial infarction within the recent 3months prior to the start of screening.

6. Patients with ongoing NYHA Classes III-IV congestive heart failure.

7. Patients with angina pectoris at rest at screening.

8. Patients with rapid atrial fibrillation at screening (rest heart rate >120/min) orany time prior to randomization from Day -21.

9. Patients with ongoing myocarditis, pericarditis, thrombophlebitis or pulmonaryembolism or who have recovered from these conditions <1 month prior to screening.Note: Patients who are on anticoagulant prophylaxis just for a pulmonary embolism orthrombophlebitis will not be subject to the one-month restriction.

10. Patient with uncontrolled hypertension characterized by seated systolic bloodpressure >180mm Hg or diastolic blood pressure >100mm Hg, within 2 months prior to,or during, the Single Blind Qualifying Period. Or patients with severe congenitalcardiac defects, severe valvular disease, suspected or known dissecting aorticaneurysm and hypertrophic cardiomyopathy should be excluded.

11. Patients with hemoglobin (HGB) <10 g/dL, aspartate aminotransferase (AST) or alanineaminotransferase (ALT) >2×upper limit of normal (ULN), hemoglobin A1C (HbA1C) >10%,or glomerular filtration rate (GFR) <30cc/min, in any of the single blind qualifyinglab tests.

12. Patient with history of bleeding diathesis or cerebral hemorrhage or seizuredisorder that need anticonvulsant.

13. Patients who have to be on ranolazine, ivabradine or calcium channel blockers otherthan, amlodipine, verapamil, nicardipine or diltiazem, and patients who have to beon more than one beta blockers and/or calcium channel blockers, or otheranti-anginal agent other than only sublingual nitroglycerin for on-demand anginarelief.

14. Patients who have to be on digoxin, digitalis, or other herbal products containingDanshen (Radix Salviae Miltiorrhizae, RSM), Sanqi (Radix Notoginseng, RN) or Ginkgobiloba during the single-blind screening and/or double-blind treatment period.

15. Patients on antiplatelet drugs (except aspirin or clopidogrel), statins, ACEinhibitor, angiotensin II receptor blocker (ARB), warfarin or other direct actingoral anticoagulants (DOACs) need to be stable at current dose for at least 2 weeksprior to the start of screening.

16. Clinical trials/experimental medication: participation in any other clinical trialor receipt of an investigational drug or device within 30 days prior to the start ofscreening.

17. Female patients with known, suspected or planned pregnancy, or lactation.

18. Patients with a recent (within the last 2 years) history of substance abuse (alcohol, marijuana, or known drug dependence). Or patients who have a positiveurine substance screening test at the Day -21 initial visit.

19. Any family member or relative of the study site staff, sponsor or CRO.

20. Patients with any other severe or serious condition that, in the opinion of theinvestigator is likely to prevent compliance with the study protocol or pose asafety concern if the patient participates in the study.

21. Patients whose QTcF (Fridericia's method corrected QT interval) is >460 ms in maleand >470 ms in female during supine 12-lead ECG at rest at screening or any timeprior to randomization from Day -21. And patients who are currently taking anymedication that are known to prolong the QTcF interval at screening or any timeprior to randomization from Day -21.