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A multicenter randomized double-blind controlled trial of FuFangDanShenPian tablet on the improvement of cardiac function after PCI in patients with acute myocardial infarction

A multicenter randomized double-blind controlled trial of FuFangDanShenPian tablet on the improvement of cardiac function after PCI in patients with acute myocardial infarction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068681
Enrollment
Unknown
Registered
2023-02-27
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure after PCI in acute myocardial infarction

Interventions

Control group:Basic treatment (according to the PCI postoperative guidelines for acute myocardial infarction) + placebo (3 po tid)
Test group:Basic treatment (according to the PCI postoperative guidelines for acute myocardial infarction) + FuFang'DanshenPian(3 po tid)

Sponsors

the First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) patients who meet the diagnostic criteria of acute myocardial infarction; (2) patients aged between 18 and 65, regardless of gender; (3) emergency PCI surgery within 12 hours from onset to admission; (4) patients who voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: (1) stable angina pectoris and unstable angina pectoris; (2) Killip grade 4 of acute myocardial infarction; (3) acute myocardial infarction with mechanical complications; (4) severe arrhythmias (such as rapid atrial fibrillation, ventricular tachycardia, high atrioventricular block, etc.); (5) patients with previous history of chronic heart failure or old myocardial infarction. (6) patients with cardiomyopathy, rheumatic heart disease, severe valvular heart disease, pericardial tamponade, acute hypertension, pulmonary hypertension, severe chronic obstructive pulmonary disease or asthma, severe infection, etc. (7) patients with severe liver (ALT >= 3 times the normal upper limit), kidney (Cr >= 265 umol / L), endocrine, hematopoietic system and other primary diseases or mental illness; (8) patients with malignant tumors. (9) allergic constitution, or allergic to a variety of drugs and food, or known to be allergic to the ingredients of compound Danshen tablets; (10) patients who cannot take care of themselves or oral drugs; (11) patients who participate in other clinical studies within three months; (12) patients who are suspected or do have a history of alcohol or drug abuse; (13) pregnant or lactating women; (14) patients with a history of cerebrovascular accidents and major operations and injuries within half a year. (15) patients who need long-term anticoagulation, HAS-BLED bleeding score >= 4, multiple cerebral infarction and cerebral aneurysm.

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction, LVEF;Minnesota Heart failure scale score;

Secondary

MeasureTime frame
Syndrome score of traditional Chinese medicine;BNP;hs-CRP;6-minute walking test;

Countries

China

Contacts

Public ContactLuo Chuanjin

the First Affiliated Hospital of Guangzhou University of Chinese Medicine

lcj_0124@126.com13560003516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026