NCT05410925 Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
| NCT ID | NCT05410925 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | ST Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,260 participants |
| Start Date | 2023-04-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,260 participants in total. It began in 2023-04-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
As an effective treatment for acute ST-segment elevation myocardial infarction (STEMI), early reperfusion may reduce the infarct size and improve the prognosis of patients. However, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to primary percutaneous coronary intervention (PCI) improves outcomes in patients undergoing the procedure within 120 minutes. In this investigator-initiated, prospective, multi-center, randomized, double-blind, placebo-controlled trial, subjects meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trial group (r-SAK) or the control group (placebo). The risk of major adverse cardiovascular events within 90 days will be observed.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years, weight ≥45 kg 2. Diagnosed as STEMI (meeting the following two conditions simultaneously) 1. Ischemic chest pain lasts ≥ 30 minutes 2. ECG indicates that ST-segment elevation of two or more contiguous precordial leads ≥ 0.1 mV, or ST-segment elevation of two or more contiguous precordial leads ≥ 0.2 mV 3. Time from onset of persistent chest pain to randomization ≤12 hours 4. Primary PCI expected to be performed ≥30 minutes, and ≤120 minutes Exclusion Criteria: 1. Cardiogenic shock 2. Active bleeding or known at high risk of bleeding (including grade Ⅲ or Ⅳ retinopathy or retinal gastrointestinal or urinary tract hemorrhage within the past 1 month) 3. Ischemic stroke or TIA in the past 6 months 4. History of hemorrhagic stroke 5. Known intracranial aneurysm 6. Severe trauma, surgery or head injury within 1 month 7. Suspected aortic dissection or infective endocarditis 8. Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture) 9. Currently taking anticoagulants 10. Poorly controlled hypertension ( ≥180/110 mmHg) 11. Severe hepatic or renal impairment indicated by the consultation or previous history (glutamic-pyruvic transaminase or glutamic oxalacetic transaminase \>3 times upper limit of normal value; eGFR \<15 ml/min/1.73m\^2, calculated based on CKD-EPI) 12. Known allergy to r-SAK 13. Pregnancy, lactation, or planning for pregnancy 14. History of chronic total occlusion, myocardial infarction or CABG 15. Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset 16. Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators
Contact & Investigator
Chunjian Li, PHD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT05410925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05410925 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05410925 currently recruiting?
Yes, NCT05410925 is actively recruiting participants. Contact the research team at lijay@njmu.edu.cn for enrollment information.
Where is the NCT05410925 trial being conducted?
This trial is being conducted at Nanjing, China, Changzhou, China, Changzhou, China, Changzhou, China and 11 additional locations.
Who is sponsoring the NCT05410925 clinical trial?
NCT05410925 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Chunjian Li, PHD at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 2,260 participants.