Last updated: September 2, 2021
Sponsor: Beijing Anzhen Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Hypercholesterolemia
Blood Clots
Cardiovascular Disease
Treatment
N/AClinical Study ID
NCT04493840
2019013
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 and <75 years.
- First-time acute anterior STEMI scheduled for primary PCI.
- ST segment elevation in at least two contiguous precordial leads according toelectrocardiogram (>30 min).
- Symptoms onset ≤12 hours.
- The presence of proximal or middle left anterior descending branch (LAD) occlusionwith pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram.
- Written informed consent.
Exclusion
Exclusion Criteria:
- Cardiogenic shock, serious heart failure (Killip class III or above), malignantventricular arrhythmia, or mechanical complications.
- Post cardiopulmonary resuscitation (CPR) (including cardioversion).
- Patients who have received thrombolytic therapy or upstream GPIIb/IIIa inhibitors (GPI).
- Uncontrolled hypertension (systolic BP ≥180 mm Hg or a diastolic BP ≥110 mmHg).
- Prior myocardial infarction, PCI or coronary artery bypass graft.
- Known severe hepatic insufficiency (AST/ALT >3-fold the upper limit of normal value)or known renal insufficiency.
- Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year.
- Patients with active bleeding, intracranial hemorrhage, major surgery or trauma within 1 months, or ischemic stroke or transient ischemic attack (TIA) within 6 months.
- History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<100×109/L).
- Patients who require simultaneous intervention of left main disease during primary PCIor those with multi-vessel disease who plan to intervene in non-culprit vessels within 7 days (simultaneous or staged).
- Scheduled for CABG within one month after randomization.
- Pregnancy, lactation, or potentially fertile women.
- Patients who have known to be allergic to Shenfu Injection or its components orpatients with serious adverse effect.
- Patients with contraindication to CMR (metal foreign body in the body, claustrophobia,etc.).
- Participation in other clinical trial in recent 3 months.
- Patients who cannot complete this trial or comply with the protocol.
Study Design
Total Participants: 326
Study Start date:
July 30, 2020
Estimated Completion Date:
August 31, 2022
Study Description
Connect with a study center
Beijing Anzhen Hospital, Capital Medical University
Beijing,
ChinaActive - Recruiting
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