NCT07110415 Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction
| NCT ID | NCT07110415 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | SPH Qingdao Growful Pharmacetical Co.,Ltd |
| Condition | Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,708 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2030-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,708 participants in total. It began in 2025-11-06 with a primary completion date of 2030-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized controlled trial was conducted to evaluate the efficacy and safety of Yangxinshi tablets in improving the condition of patients with coronary heart disease complicated by cardiac dysfunction.
Eligibility Criteria
Inclusion Criteria: 1. For inpatients diagnosed with coronary heart disease (including acute coronary syndrome and chronic coronary syndrome), it is up to the doctor to decide whether to undergo revascularization and what kind of revascularization to use. 2. Patients aged between 40 and 80 years (inclusive), regardless of sex; 3. Patients with NYHA cardiac function classes II-IV; 4. Patients with NT-proBNP \> 125 pg/mL (or BNP\>35 pg/mL); 5. The syndrome differentiation in traditional Chinese medicine conforms to chest obstruction (qi deficiency and blood stasis syndrome) 6. Patients who voluntarily participated and signed an informed consent form. Exclusion Criteria: 1. Patients with STEMI within 3 days; 2. Patients at extremely high risk of NSTEMI (hemodynamic instability, cardiogenic shock, new-onset heart failure or aggravated heart failure, severe ventricular arrhythmia) 3. Patients with acute myocardial infarction complicated with cardiogenic shock, mechanical complications, respiratory failure and other multiple organ failure; 4. Patients with severe liver dysfunction (transaminase levels more than three times the upper limit of normal), renal insufficiency (eGFR \< 30mL/min/1.73m2), acute infectious diseases, and mental disorders;以上翻译结果来自有道神经网络翻译（YNMT）· 通用场景 5. Patients with drug-resistant hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); 6. Pregnant or lactating women, or those planning pregnancy during the study period; 7. Patients who cannot tolerate 3 months of dual antiplatelet therapy; 8. Patients with allergic reactions or abnormal drug reactions to the study drug or any of its excipients; 9. Patients who have regularly taken Yangxinshi tablets and similar traditional Chinese medicine, Chinese patent medicine or traditional Chinese medicine decoction with the same curative effectin the past month; 10. Patients who have participated in other clinical drug trials within the last three months; 11. Patients with malignant tumors and other pathological conditions with an expected survival of less than 3 years; 12. Patients whom the investigator deems unsuitable for participating in the clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07110415 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Coronary Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07110415 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07110415 currently recruiting?
Yes, NCT07110415 is actively recruiting participants. Contact the research team at hanyaling@263.net for enrollment information.
Where is the NCT07110415 trial being conducted?
This trial is being conducted at Haozhou, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07110415 clinical trial?
NCT07110415 is sponsored by SPH Qingdao Growful Pharmacetical Co.,Ltd. The trial plans to enroll 2,708 participants.