Status:
UNKNOWN
Early Intracoronary Administration of Fasudil in the Primary PCI of ST-segment-Elevation Myocardial Infarction
Lead Sponsor:
RenJi Hospital
Conditions:
ST Segment Elevation Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study aims to evaluate whether an early intracoronary administration of Fasudil Hydrochloride during primary PCI of STEMI can improve epicardial and myocardial perfusion as well as clinical outcom...
Detailed Description
Timely reperfusion therapy is the most effective treatment for acute STEMI patients. Primary PCI has been documented as the best method for restoration of epicardial blood flow. Nevertheless, recovery...
Eligibility Criteria
Inclusion
- Age: over 18 or 18 years old, less than 75 years old;
- Patents with myocardial infarction who have symptom onset within 6h before randomization;
- ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
- Signed informed consent form prior to trial participation
Exclusion
- ECG with new left bundle branch block;
- Contraindications for CMR
- Repeated STEMI
- History of cardiovascular diseases
- PCI within previous 1 month or Previous coronary-artery bypass surgery (CABG)
- Previously known multi-vessel coronary artery disease not suitable for revascularization
- Hospitalization for cardiac reason within past 48 hours
- Known acute pericarditis and/or subacute bacterial endocarditis
- Arterial aneurysm, arterial/venous malformation and aorta dissection;
- History of other severe diseases
- Any other diseases with life expectancy ≤12 months
- • Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia; Known acute pancreatitis
- Severe cardiac complications
- Any sign of cardiac rupture
- Cardiogenic shock (SBP \<90 mmHg after fluid infusion or SBP\<100 mmHg after vasoactive drugs)
- Not suitable for clinical trial
- Inclusion in another clinical trial;
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
- Pregnancy or lactating;
- Body weight \<40kg or \>125kg;
- Known allergy to any drug that may appear in the study
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03753269
Start Date
July 1 2019
End Date
December 30 2022
Last Update
November 26 2018
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