Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

This trials aims to assess, in 240 eligible patients with coronary heart disease, the effects on level of high-sensitivity C-reactive protein (hsCRP) changes from baseline to 12 weeks of Xuesaitong Soft Capsules.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old

History of myocardial infarction

Have received coronary interventional therapy

There are symptoms of myocardial ischemia (such as chest pain) and objective evidence (stress electrocardiogram or stress myocardial perfusion imaging indicated myocardial ischemia or coronary artery stenosis ≥50% )

Disqualifiers

Acute coronary syndrome occurred or received percutaneous coronary intervention therapy within the past 3 months

Previously received coronary artery bypass grafting

Stroke occurred within the previous 3 months

Symptomatic heart failure (HF) in the past, or documented left ventricular ejection fraction < 35%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xuesaitong Soft Capsule

    Drug

    Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.

  • Placebo

    Drug

    Each participant in the placebo group will take matching placebo.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Xuesaitong Soft CapsuleExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

hsCRP

Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks

Time frame
12 weeks

Secondary outcomes

1

Other inflammation indicators

Changes in levels of interleukin-6, interleukin-10, interleukin-1β, tumor necrosis factor-α from baseline at 12 weeks

Time frame
12 weeks
2

IPA

Changes in level of inhibition of platelet aggregation from baseline at 12 weeks

Time frame
12 weeks
3

Vascular endothelial function

Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks

Time frame
12 weeks
4

Blood lipid profiles

Changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, small low-density lipoprotein cholesterol, and triglyceride levels from baseline at 12 weeks

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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