T89 for Stable Angina

Overseen By Ruoling Guo, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tasly Pharmaceuticals, Inc.

Must be taking: Beta blockers, Calcium channel blockers

Must not be taking: Ranolazine, Ivabradine, Digoxin, Digitalis

Disqualifiers: Unstable angina, Myocardial infarction, Congestive heart failure, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

765 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests T89, a new medication for people with stable angina. It aims to see if T89 can help the heart get more oxygen during exercise, reducing chest pain and improving exercise ability. The study evaluates the safety and effectiveness of T89 over time.

Will I have to stop taking my current medications?

Participants must stop taking all non-beta blocker and non-calcium channel blocker anti-anginal medications. If you are on a beta blocker or a calcium channel blocker, you can only continue with one of them, but not both. Other medications like nitroglycerin tablets provided by the sponsor can be used for angina relief during the trial.

Research Team

Henry H Sun, PhD, MD

Principal Investigator

Tasly Pharmaceuticals, Inc.

Eligibility Criteria

Adults aged 18-90 with stable angina and documented coronary artery disease, who can perform exercise tolerance tests (ETT), are eligible. They must not be on certain heart medications or have had recent heart procedures. Women of childbearing age need a negative pregnancy test and agree to birth control use.

Inclusion Criteria

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

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

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

Exclusion Criteria

Patients with contraindication to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform ETT, in the opinion of investigator, including but not limited to: hospitalization for acute exacerbation of chronic lung disease within 4 weeks prior to the start of screening, current home oxygen use, needs for cardiac glycoside therapy, functionally limiting peripheral arterial disease, physical disability or other intercurrent illness such as acute respiratory infection/illness that, in the opinion of the Investigator or Sub-investigator, may interfere with the ability to perform ETT.

*Left ventricular hypertrophy (LVH) without repolarization abnormalities is not considered an exclusion criterion.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

2 visits (in-person)

Treatment

Participants receive double-blind treatment with T89 or placebo for 8 weeks, with exercise tolerance tests conducted at weeks 6 and 8

8 weeks

2 visits (in-person)

Open-label extension

Participants receive T89 at a daily dose of 600 mg for long-term safety assessment

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo capsule
• T89 capsule

Trial Overview The trial is testing the safety and effectiveness of T89 capsules compared to placebo in treating stable angina over three periods: a qualifying run-in period, an 8-week double-blind treatment period assessed by ETT, followed by a long-term open-label safety evaluation.

Participant Groups

Group I: T89 low-dose group Experimental Treatment 2 Interventions

T89 capsule is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi. Placebo capsule does not contain any amount of active substance. Subjects in this group will use three T89 capsules and one Placebo capsule each time by oral administration twice daily for 8 weeks.

Group II: T89 high-dose group Experimental Treatment 1 Intervention

T89 capsule is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi. Subjects in this group will use four T89 capsules each time by oral administration twice daily for 8 weeks.

Group III: Placebo group Placebo Group 1 Intervention

Placebo capsule does not contain any amount of active substance. Subjects in this group will use four Placebo capsules each time by oral administration twice daily for 8 weeks.

Who Is Running the Clinical Trial?

Tasly Pharmaceuticals, Inc.

Lead Sponsor

Trials

23

Recruited

5,600+