Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol

NCT06845254 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2024XLA098-3
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effects of Xuesaitong soft capsules on platelet function, clinical efficacy, prognosis, and safety in the treatment of acute coronary syndrome, 400 patients with acute coronary syndrome who underwent PCI were treated with Xuesaitong soft capsules (mainly containing ginsenosides) for 12 weeks.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; traditional Chinese medicine; Total saponins of Panax notoginseng

Outcome Measures

Primary Outcomes (2)

• Changes in thromboelastography induced by AA, including R value, K value , α angle , MA value , CI, TPI， LY30, and AAYZL, before and after treatment, as assessed by thromboelastography.

  This outcome measure will assess changes in thromboelastography induced by AA, including R value (reaction time), K value (coagulation time), αangle (alpha angle), MA value (maximum amplitude), CI (coagulation index), TPI (thrombodynamic potential index)， LY30 (amplitude at 30 minutes), and AAYZL Percentage platelet clotting inhibition of AA), before and after treatment. Data will be summarized based on the change in levels of each marker from baseline to post-treatment, and any significant changes will be noted.

  12 weeks

• Changes in thromboelastography induced by ADP, including R value, K value , α angle , MA value , CI, TPI， LY30, and ADPYZL, before and after treatment, as assessed by thromboelastography.

  This outcome measure will assess changes in thromboelastography induced by ADP, including R value (reaction time), K value (coagulation time), αangle (alpha angle), MA value (maximum amplitude), CI (coagulation index), TPI (thrombodynamic potential index)， LY30 (amplitude at 30 minutes), and ADPYZL（ Percentage platelet clotting inhibition of ADP), before and after treatment. Data will be summarized based on the change in levels of each marker from baseline to post-treatment, and any significant changes will be noted.

  12 weeks

Secondary Outcomes (24)

• Changes in platelet granule markers, including platelet factor 4 (PF4) and β-thromboglobulin, before and after treatment, as assessed by ELISA

  12 weeks

• Changes in platelet surface activation markers and platelet-neutrophil aggregation before and after treatment, as assessed by flow cytometry

  12 weeks

• Changes in endothelial function markers, including plasma soluble vascular cell adhesion molecule 1 (VCAM-1), soluble intercellular adhesion molecule 1 (ICAM-1), vascular hemophilic factor (vWF), before and after treatment, as assessed by ELISA

  12 weeks

• Changes in inflammatory markers, including serum hs-CRP, IL-11,IL-6,MCP-1,MMP-9,CD40L,before and after treatment, as assessed by ELISA.

  12 weeks

• ejection fraction

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) + Xuesaitong soft capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12 weeks

Drug: Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)

Control group

PLACEBO COMPARATOR

Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) +Placebo capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12 weeks

Drug: placebo capsule

Interventions

Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins) DRUG

Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) + Xuesaitong soft capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12 weeks.

Intervention group

placebo capsule DRUG

Routine western medicine treatment (oral drug therapy and standard percutaneous coronary intervention) + placebo capsule, 0.33g/ tablets, 2 tablets each time, twice a day. The treatment period is 12weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Within 4 weeks post-PCI.
• Aged between 18 and 80 years, both male and female.
• Voluntarily participating in the clinical trial, having signed the informed consent form.

You may not qualify if:

• Uncontrolled hypertension after medication (systolic BP \>180mmHg or diastolic BP \> 110mmHg).
• History of gastrointestinal ulcers or significant gastrointestinal bleeding.
• Severe organic heart disease, such as LVEF \< 35% or NYHA/Killip heart function grade IV.
• History of malignant arrhythmias within the past year (arrhythmias affecting hemodynamics requiring medication or electrical cardioversion, or requiring CPR), congenital heart disease, or malignant tumors.
• Severe liver or kidney dysfunction: ALT or AST ≥ 3×ULN, TBIL≥ 2×ULN, or creatinine clearance \< 30ml/min.
• Pregnant or lactating women.
• Recent blood donation or significant blood loss within the past 3 months (≥400ml).
• History of alcohol abuse (≥28 standard units/week for males, ≥21 standard units/week for females) or frequent alcohol consumption in the past 6 months (≥14 standard units/week).
• History of drug abuse or dependence within the past year. Participation in other clinical trials and taking trial drugs within the past 3 months.
• Allergy or intolerance to aspirin or P2Y12 receptor inhibitors.
• Allergy to any components of the trial drug.
• Other conditions deemed inappropriate for participation by the nvestigator

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Dazhuo Shi, professor

CONTACT

010-62835303; shidazhuo@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)