Actively Recruiting
Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients With Stable Angina
Led by Tasly Pharmaceuticals, Inc. · Updated on 2025-04-09
765
Participants Needed
1
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group phase 3 clinical study to confirm the safety and efficacy of T89 in patients with stable angina pectoris, with an extended open-label period to evaluate the long-term safety of T89. This study includes three main periods: the first study period is a 3-week single-blind qualifying run-in period to screen eligible stable angina patients by exercise tolerance test (ETT). The second study period is a 8-week double-blind treatment period to evaluate the efficacy and safety of T89 in patients with stable angina by ETT. And, the last study period is a 44-week open-label period to observe long-term use safety of T89.
CONDITIONS
Official Title
Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients With Stable Angina
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign a written informed consent
- Males and females aged 18 to 90 years
- History of chronic stable angina triggered by physical effort and relieved by rest or sublingual nitroglycerin
- Able to withdraw all anti-anginal medications except one beta blocker or one calcium channel blocker (amlodipine, diltiazem, verapamil, or nicardipine) and maintain this treatment from Day -21 until end of double-blind period
- Agreement from cardiac care provider if anti-anginal treatment is modified
- Use of sponsor-provided nitroglycerin tablets allowed for on-demand angina relief during qualifying and treatment periods
- Documented coronary artery disease with previous myocardial infarction at least 3 months prior to screening, or ischemic heart disease confirmed by stress myocardial imaging, or coronary artery stenosis ≥50% by angiography or CT
- Able and willing to comply with study procedures and understand Seattle Angina Questionnaire and diary cards
- Women of childbearing potential and male partners must use birth control from screening start until 3 months after last dose; females must have negative pregnancy tests at screening and randomization
- Experience at least two angina episodes from Day -14 to Day 1, with at least two episodes recorded by WCM
- Have two qualifying exercise tolerance tests on standard Bruce protocol on Day -7 and Day 1 meeting specific criteria
You will not qualify if you...
- Chest pain not related to angina or non-cardiac chest pain
- Conditions preventing or interfering with exercise tolerance tests, such as recent hospitalization for lung disease, current oxygen use, need for cardiac glycosides, severe peripheral artery disease, physical disability, or acute respiratory illness
- Electrocardiographic abnormalities that interfere with exercise ECG interpretation, including Lown-Ganong-Levine Syndrome, Wolff-Parkinson-White Syndrome, left bundle branch block, pacemaker rhythm, or resting ST segment depression ≥1 mm (except LVH without repolarization abnormalities)
- Coronary revascularization procedure within 2 months prior to screening
- Unstable angina or myocardial infarction within 3 months prior to screening
- New York Heart Association class III-IV congestive heart failure
- Angina at rest at screening
- Rapid atrial fibrillation (resting heart rate >120/min) prior to randomization
- Ongoing or recent myocarditis, pericarditis, thrombophlebitis, or pulmonary embolism within 1 month
- Uncontrolled hypertension (systolic >180 mm Hg or diastolic >100 mm Hg) within 2 months prior or during qualifying period
- Severe congenital cardiac defects, severe valvular disease, suspected or known dissecting aortic aneurysm, or hypertrophic cardiomyopathy
- Low hemoglobin (<10 g/dL), elevated liver enzymes (AST or ALT >2x ULN), high HbA1c (>10%), or low kidney function (GFR <30 cc/min) during qualifying labs
- History of bleeding disorders, cerebral hemorrhage, or seizure disorder requiring anticonvulsants
- Need for ranolazine, ivabradine, or certain calcium channel blockers other than specified, or multiple beta blockers/calcium channel blockers, or other anti-anginal agents besides sublingual nitroglycerin
- Use of digoxin, digitalis, or herbal products containing Danshen, Sanqi, or Ginkgo biloba during screening and treatment
- Use of antiplatelet drugs (except aspirin or clopidogrel), statins, ACE inhibitors, ARBs, warfarin, or direct oral anticoagulants without stable dose for at least 2 weeks before screening
- Participation in another clinical trial or use of investigational drug/device within 30 days before screening
- Known, suspected, or planned pregnancy or lactation
- Recent history (within 2 years) of substance abuse or positive urine substance test at screening
- Family member or relative of study staff, sponsor, or CRO
- Any severe condition that may prevent compliance or pose safety concerns
- QTcF interval >460 ms in males or >470 ms in females during ECG at screening or prior to randomization, or use of medications known to prolong QTcF interval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Southwest Florida Research LLC
Naples, Florida, United States, 34102
Actively Recruiting
Research Team
H
Henry H Sun, PhD, MD
CONTACT
R
Ruoling Guo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here