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New treatment option for Chronic Stable Angina Pectoris
Official title Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients With Stable Angina
ClinicalTrials.gov ID: NCT03789552
What this study is testing
What is T89 capsule?
T89 capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic stable angina pectoris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Willing to participate and sign a written informed consent
- Males and females ≥ 18 and ≤90 years old.
- Medical history of chronic stable angina triggered by physical effort and relieved by rest or sublingual nitroglycerin.
- Patients who agree and in the opinion of the investigator are able to withdraw all non-beta blocker and all non-calcium channel blocker anti-anginal...
- Documented history of coronary artery disease with one or more of the following conditions: 5.1) History of previous myocardial infarction (previous...
You likely can't join if
- Patients with only non-cardiac chest pain or cardiac chest pain not related to angina.
- Patients with contraindication to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform ETT, in the...
- Patients with presence of electrographic or other abnormalities/factors that could interfere with exercise ECG interpretation or may lead to a false...
- Patients with history of any coronary revascularization procedure (e.g. PCI or CABG) within 2 months prior to the start of screening.
- Patients who had unstable angina, or myocardial infarction within the recent 3 months prior to the start of screening.
- Patients with ongoing NYHA Classes III-IV congestive heart failure.
See the full eligibility criteria
Who can join
- Willing to participate and sign a written informed consent
- Males and females ≥ 18 and ≤90 years old.
- Medical history of chronic stable angina triggered by physical effort and relieved by rest or sublingual nitroglycerin.
- Patients who agree and in the opinion of the investigator are able to withdraw all non-beta blocker and all non-calcium channel blocker anti-anginal medications. For those people who are on beta blockers and/or calcium...
- Documented history of coronary artery disease with one or more of the following conditions: 5.1) History of previous myocardial infarction (previous MI that occurred and was diagnosed at least 3 months prior to start of...
- 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.
- Women of child bearing potential: Female patients of child-bearing potential or male patients with partners of child-bearing potential must use appropriate birth control from the start of screening, until 3 months after...
- Patient must experience two or more angina episodes from Day-14 to Day 1, as the baseline frequency of angina. At least two of the angina episodes must be recorded by WCM (Other written forms of recording/reporting...
- To be qualified, patients must have two qualifying ETTs on standard Bruce protocol on Day- 7 and Day 1. The qualifying ETTs are:
- ETTs must meet the positive ETT criteria;
- Total exercise duration (TED) of the positive ETT is between 3-12 minutes of exercise;
- The difference in TED between the two ETTs must not exceed 15% of the longer one.
- 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...
What rules you out
- Patients with only non-cardiac chest pain or cardiac chest pain not related to angina.
- 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...
- Patients with presence of electrographic or other abnormalities/factors that could interfere with exercise ECG interpretation or may lead to a false positive stress test (including but not limited to, Lown-Ganong-Levine...
- Patients with history of any coronary revascularization procedure (e.g. PCI or CABG) within 2 months prior to the start of screening.
- Patients who had unstable angina, or myocardial infarction within the recent 3 months prior to the start of screening.
- Patients with ongoing NYHA Classes III-IV congestive heart failure.
- Patients with angina pectoris at rest at screening.
- Patients with rapid atrial fibrillation at screening (rest heart rate \>120/min) or any time prior to randomization from Day -21.
- Patients with ongoing myocarditis, pericarditis, thrombophlebitis or pulmonary embolism or who have recovered from these conditions \<1 month prior to screening. Note: Patients who are on anticoagulant prophylaxis just...
- Patient with uncontrolled hypertension characterized by seated systolic blood pressure \>180mm Hg or diastolic blood pressure \>100mm Hg, within 2 months prior to, or during, the Single Blind Qualifying Period. Or...
- Patients with hemoglobin (HGB) \ 2×upper limit of normal (ULN), hemoglobin A1C (HbA1C) \>10%, or glomerular filtration rate (GFR) \<30cc/min, in any of the single blind qualifying lab tests.
- Patient with history of bleeding diathesis or cerebral hemorrhage or seizure disorder that need anticonvulsant.
- Patients who have to be on ranolazine, ivabradine or calcium channel blockers other than, amlodipine, verapamil, nicardipine or diltiazem, and patients who have to be on more than one beta blockers and/or calcium...
- Patients who have to be on digoxin, digitalis, or other herbal products containing Danshen (Radix Salviae Miltiorrhizae, RSM), Sanqi (Radix Notoginseng, RN) or Ginkgo biloba during the partly blinded screening and/or...
- Patients on antiplatelet drugs (except aspirin or clopidogrel), statins, ACE inhibitor, angiotensin II receptor blocker (ARB), warfarin or other direct acting oral anticoagulants (DOACs) need to be stable at current...
- Clinical trials/experimental medication: participation in any other clinical trial or receipt of an investigational drug or device within 30 days prior to the start of screening.
- Female patients with known, suspected or planned pregnancy, or lactation.
- Patients with a recent (within the last 2 years) history of substance abuse (alcohol, marijuana, or known drug dependence). Or patients who have a positive urine substance screening test at the Day -21 initial visit.
- Any family member or relative of the study site staff, sponsor or CRO.
- Patients with any other severe or serious condition that, in the opinion of the investigator is likely to prevent compliance with the study protocol or pose a safety concern if the patient participates in the study.
- Patients whose QTcF (Fridericia's method corrected QT interval) is \>460 ms in male and \>470 ms in female during supine 12-lead ECG at rest at screening or any time prior to randomization from Day -21. And patients who...
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.