NCT06171061 Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
| NCT ID | NCT06171061 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shandong First Medical University |
| Condition | Chronic Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2025-12-31 |
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 1,200 participants in total. It began in 2023-12-18 with a primary completion date of 2025-12-31.
⚠ 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
This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).
Eligibility Criteria
Inclusion Criteria: 1. age 18-75 years; 2. CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or \>3 months after coronary revascularization; 3. moderately to severely limited exercise tolerance: the maximum 6MWD is \< 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is \< 5 METs; 4. voluntary participation and signing of informed consent. Exclusion Criteria: 1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT); 2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan; 3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months; 4. subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.
Contact & Investigator
Yuan Haitao
PRINCIPAL INVESTIGATOR
Shandong Provincial Hospital
Frequently Asked Questions
Who can join the NCT06171061 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Coronary Syndrome. 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 NCT06171061 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 NCT06171061 currently recruiting?
Yes, NCT06171061 is actively recruiting participants. Contact the research team at doctoryuanht@126.com for enrollment information.
Where is the NCT06171061 trial being conducted?
This trial is being conducted at Chongqing, China, Zhengzhou, China, Binzhou, China, Binzhou, China and 11 additional locations.
Who is sponsoring the NCT06171061 clinical trial?
NCT06171061 is sponsored by Shandong First Medical University. The principal investigator is Yuan Haitao at Shandong Provincial Hospital. The trial plans to enroll 1,200 participants.