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Study on the Safety and Effectiveness of Guanxinning Tablets in Intensive Therapy for Patients with Acute Coronary Syndrome

Phase 4
Conditions
Acute Coronary Syndrome
Registration Number
ITMCTR2100005434
Lead Sponsor
Hangzhou First People's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Diagnostic criteria for acute myocardial infarction: elevated cardiac troponin (cTn), at least once the value is higher than the upper limit of 99% of the reference value, and at least one of the following: ? symptoms of acute myocardial ischemia; ? new ischemia ECG changes; ? pathological Q waves; (4) imaging evidence of newly viable myocardium loss or new segmental ventricular wall motion abnormalities. If ECG manifests as ST-segment elevation in two or more adjacent leads, new left bundle branch block or hyperacute T wave changes, it is defined as SETMI. If there is no ST-segment elevation on the ECG at the time of consultation, it is defined as NSTEMI. Diagnostic criteria for unstable angina (UA): ?Including first-onset exertional angina, worsening exertional angina, resting angina, and variant angina; ?ischemic chest pain time =30min; ?The ECG showed ST-segment level or Decline depression = 1 mm or ST segment elevation (limb leads = 1 mm, chest leads = 2 mm), after the onset, the ST segment returns to the level before the onset; ? no changes in blood myocardial necrosis markers.

Exclusion Criteria

?Age <18 years; ?Recent fever, various acute and chronic infections, past strokes, malignant tumors, rheumatic connective tissue disease, etc.; ?Severe heart, liver, and kidney insufficiency; ?Recent activities (2-4 weeks) Visceral hemorrhage, including head trauma, cardiopulmonary resuscitation, major surgery, puncture on large blood vessels that cannot be compressed, or known bleeding tendency; ?Severe and uncontrolled hypertension at admission (>180/110mmHg) ); ? pregnant women, breast-feeding women; ? allergic constitution, or food allergies to multiple drugs; (8) patients who have participated in clinical trials of other drugs within 1 month.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Antiplatelet aggregation rate;Inflammation-related factors (TNF-a, IL-1, IL-6, IL-10);Hypersensitive-c-reactive-protein;Oxidative stress indicators (SOD, ROS);Troponin T;Nitric Oxide;Electrocardiogram;Creatine Kinase, MB Form;
Secondary Outcome Measures
NameTimeMethod
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