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T89 for Chronic Stable Angina Pectoris

This study is testing T89 capsules to see if they can help people with chronic stable angina pectoris (chest pain caused by reduced blood flow to the heart, often triggered by physical effort). Researchers want to confirm if T89 is effective and safe. You would receive either T89 capsules or a placebo capsule (an inactive substance that looks like the study drug). The main goal is to see how much your exercise duration improves after taking the study drug for about 8 weeks. This study is looking for people aged 18 to 90 who have stable angina. The current status of this study is unclear.

Study design
This is a multi-center, double-blind (neither you nor your doctor will know if you're getting T89 or placebo), randomized (assigned by chance), placebo-controlled study with an open-label period. It plans to enroll 765 participants.
What's involved
You would first have a 3-week screening period, followed by an 8-week period where you take T89 or placebo twice daily. There will be exercise tolerance tests (ETT) at different points, and a 44-week open-label period to observe long-term safety.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 57 (about 8 weeks), but there is an extended 44-week open-label period to observe long-term safety.

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NCT03789552

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

Recruiting
PHASE3Ages 18–90InterventionalTreatment
Tasly Pharmaceuticals, Inc.
~765 participants
Updated 2025-04-09 on ClinicalTrials.gov
What's tested:T89 capsulePlacebo capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57
Measured over Day 57 (post drug administration from randomization)

Conditions

Chronic Stable Angina Pectoris

Explore related trials

Stable Angina

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Henry H Sun, PhD, MD · STUDY_CHAIR · Tasly Pharmaceuticals, Inc.

Who to contact

Henry H Sun, PhD, MD
[email protected]
301-978-3905
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57Day 57 (post drug administration from randomization)

    Exercise, a common physiological stress, can elicit cardiovascular abnormalities that are not present at rest, and it can be used to determine the adequacy of cardiac function. Clinical exercise tolerance test (ETT) is an established non-invasive procedure that provides diagnostic and prognostic information for the evaluation of several pathologies, the most common of which is coronary heart disease. Total exercise duration (TED) is the time from starting ETT to terminating ETT, usually presented by minutes and seconds. Standard Bruce protocol, one of the protocols used for the conduction of an ETT as a pre-defined speed and gradient in different time interval, will be applied in this study. The TED at each ETT will be collected and recorded as primary parameter, and the change from baseline of symptom-limited TED at trough drug levels on standard Bruce protocol to Day 57 of treatment in high-dose and low-dose groups will be compared with that in placebo group.