Clinical trial
Clinical Study on Reducing Myocardial Infarction Siez After Primary PCI in Patients With ST Segment Elevation Myocardial Infarction by Using Henagliflozin
Name
Henagliflozin for infarction
Description
This Randomized controlled intervention study recruited patients diagnosed with ST-segment elevation myocardial infarction (STEMI). A total of 240 patients were enrolled in either Henagliflozin group or control group. Patients in Henggliflozin group will be given by oral administration of Henggliflozin for 6 months post acute myocardial infarction. Prior to procedure, dynamic changes in myocardial enzymes were monitored. Major cardiovascular events, including non-fatal myocardial infarction, all-cause death, revascularization due to angina, and hospitalization for acute heart failure. This study aims to assess the impact of Henggelizin intervention on the reduction of myocardial infarction size (evaluated by cardiac enzyme) and improvement of left ventricular remodeling in patients with ST-segment elevation myocardial infarction.
Trial arms
Trial start
2023-07-01
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Recruiting
Phase
Early phase I
Treatment
Henagliflozin
After primary PCI, Henggliflozin or Placebo was administered within 24 hours, followed by daily oral administration until 6 months post-acute myocardial infarction.
Arms:
henagliflozein group
Size
240
Primary endpoint
Area under the curve of myocardial enzymes (CK-MB)
3 days after the primary PCI
Eligibility criteria
Inclusion Criteria:
1. STEMI patients with clear diagnosis: ischemic chest pain lasting for more than 30 minutes and adjacent to two or more leads of ST Segment elevation (limb lead ≥ 0.1mV, chest lead ≥ 0.2mV) with or without elevated myocardial enzyme levels;
2. Chest pain lasting less than 12 hours;
3. Age range from 18 to 80 years old;
4. Plans to undergo primary PCI ;
5. Informed consent form
Exclusion Criteria:
1. Mechanical complications;
2. Cardiogenic shock;
3. Experienced myocardial infarction within 6 months;
4. Aortic dissection;
5. Suffering from malignant tumors, severe liver and kidney failure, respiratory failure, or other short-term progressive diseases that researchers believe cannot be included
6. Urinary system infection
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}
Updated at
2024-01-03
1 organization
1 product
2 indications
Organization
Qian GengProduct
HenagliflozinIndication
Heart AttackIndication
Congestive Heart Failure