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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new capsule called T89, made from plant extracts, for people with stable angina—a type of chest pain occurring during physical activity and relieved by rest or medication. The study aims to determine if T89 can safely and effectively reduce angina episodes and improve exercise tolerance. Participants should have a history of exercise-triggered stable angina and be willing to adjust their current medications. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that T89, a herbal medicine made from Danshen and Sanqi, is generally safe. Studies have found it to be well-tolerated, with few side effects. One important study found that doses of 150mg and 225mg did not cause major side effects, suggesting safety at these levels. Additionally, other reports indicate that T89 does not cause tolerance, maintaining its effectiveness over time. Overall, T89 has demonstrated a good safety record in the research conducted so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stable angina?

Unlike the standard treatments for stable angina, which include medications like beta-blockers, nitrates, and calcium channel blockers that primarily focus on improving blood flow or reducing heart workload, T89 offers a botanical approach. T89 is derived from the water extract of Danshen and Sanqi, which are traditional herbs believed to have cardiovascular benefits. Researchers are excited because this natural formulation targets angina differently, potentially providing relief with fewer side effects. Furthermore, its use of a botanical drug could offer an alternative for patients seeking more natural treatment options.

What evidence suggests that T89 could be an effective treatment for stable angina?

Research has shown that T89, a plant-based medicine also known as Dantonic®, may help treat stable angina. Studies have found that T89 can reduce the frequency of angina attacks, shorten their duration, and enable patients to exercise longer without discomfort. In this trial, participants will join one of three groups: the T89 low-dose group, the T89 high-dose group, or the placebo group. Previous clinical trials demonstrated that people taking T89 could exercise longer without symptoms. Additionally, T89 is considered safe, with few side effects reported. Overall, T89 appears to be an effective way to manage stable angina symptoms. ^{5 6 7 8 9}

Who Is on the Research Team?

Henry H Sun, PhD, MD

Principal Investigator

Tasly Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01659580

NCT01659580 | Phase III Trial of Dantonic® (T89) Capsule ... The primary efficiency endpoint is the change of symptom-limited Total Exercise Duration of the ETT at the end of the 4th week of treatment from the average of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10240178/

Compound danshen dripping pills vs. nitrates for stable ... A systematic review showed that TCM could reduce the frequency of angina pectoris, shorten the duration of angina attack and improve the quality ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03789552?term=AREA%5BBasicSearch%5D(T89)&rank=6

Outcome Research to Confirm the Anti-anginal Effect of ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332218347863

A review of the mechanism of action of Dantonic® ... Clinical studies in China have shown that Dantonic® is an effective and safe drug for the treatment of angina pectoris manifested with ameliorating anginal ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014028/

Advances of clinical trials on compound Danshen dripping ... The treatment group had 67.5% anti-angina efficacy, 62.5% ECG improvement, and reduced TC by 21.6% and TG by 18.3%. The control group showed ...

6. pdfs.semanticscholar.org pdfs.semanticscholar.org/f898/67a5faf25596f5549dc4ef5293076ebf37b6.pdf

The Safety and Tolerance of Herbal Anti-Angina Drug ... A meta-analysis suggests that compound salvia pellet is safe and does not develop tolerance over time [13]. However, most of the included trials were using ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01659580

Phase III Trial of Dantonic® (T89) Capsule to Prevent and ... This pivotal confirmative Phase III clinical trial is to confirm the efficacy and safety of the drug at 150mg and 225mg doses in the prevention and treatment of ...

8. scirp.org scirp.org/journal/paperinformation?paperid=36959

The Safety and Tolerance of Herbal Anti-Angina Drug ... Discover the safety and tolerance of Compound Salvia Pellet (T89) in a dose escalation study. Find out the maximum tolerance dose (MTD) in the Chinese ...

9. researchgate.net researchgate.net/publication/274000252_The_Safety_and_Tolerance_of_Herbal_Anti-Angina_Drug_Compound_Danshen_Droplet_Pill_in_Healthy_Volunteers

The Safety and Tolerance of Herbal Anti-Angina Drug ... [10-12]. ... is safe and does not develop tolerance over time [13]. ... clinical dosage of T89 is 270 mg each time, 3 times a day,. regardless of ...