unstable angina pectoris or acute myocardial infarction without Q wave, non-ST elevation acute myocardial infarction (NSTEMI)
Conditions
Interventions
Experimental group:Before PCI, Battifiban injection 220 µg/kg (0.11 mL/kg) was injected intravenously, which was completed within 1-2 minutes.
Intraoperative to postoperative PCI: Immediately after th
Placebo group:Before PCI, 0.11 mL/kg placebo was injected intravenously, which was completed within 1-2 minutes.
Intraoperative to postoperative PCI: 0.075 mL/kg/h of intravenous infusion for 24 hours
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old (including 18 years old and 75 years old), male and female; (2) Clearly diagnosed acute coronary syndromes (unstable angina pectoris, non-ST elevation myocardial infarction, and ST elevation)The diagnostic criteria for myocardial infarction refer to the 2011 ACC/AHA Treatment Guidelines) for patients requiring PCI; (3) Voluntarily participate in this experiment and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Uncontrolled hypertension (systolic >200 mmHg and/or diastolic >110 mmHg); (2) Hemorrhagic stroke or ischemic stroke within the last 6 months and a definite diagnosis of CNS structural abnormalities; (3) aortic dissection; (4) Acute stage of peptic ulcer; (5) Have received prolonged cardiopulmonary resuscitation (more than 10 minutes), surgery or serious trauma in the past 6 weeks; (6) Any of the following conditions exist: Cardiogenic shock, chronic congestive heart failure NYHA class =?, hypotension (systolic blood pressure 2.0, platelet count 300mg) are not eligible for this study from a safety perspective as determined by the researchers; (14) Those who have used GPIIb/IIIa antagonists, such as tirofiban, abciximab, and eptifibatide, within 7 days before the operation; (15) Those who have participated in other clinical trials within 3 months prior to enrollment; (16) Other situations where the researchers consider that the patient is not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoints of death at 30 days after PCI, myocardial infarction, need for target vessel revascularization including PCI, antithrombotic Therapeutic needs, no reflow, and severe slow blood Flow (TIMI Flow Grade TFG 0 and TFG 1) events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite endpoints of death at 48h and 7 days after PCI, myocardial infarction, the need for target vessel revasulation including PCI, the need for antithrombotic agents, no reflow, and severe slow Flow (TIMI Flow Grade TFG 0 and TFG 1) events.; | — |
Countries
China
Contacts
Public ContactGe Junbo
Zhongshan Hospital, Fudan University
Outcome results
None listed