NCT06171061

Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome

Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Shandong First Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).

Conditions

• Chronic Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Yangxinshi tablet	In addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks.
OTHER	Basic medication	The control group will be given basic medication only. The treatment period is 24 weeks.

Timeline

• Start date: 2023-12-18
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-12-14
• Last updated: 2024-04-17

Locations

32 sites across 1 country: China