Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: ST Elevation Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT05410925

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

2260

Starts

2023-04-08

Expected to finish

2027-12-31

Last updated by the study team

2024-10-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75 years, weight ≥45 kg
• Diagnosed as STEMI (meeting the following two conditions simultaneously)
• Ischemic chest pain lasts ≥ 30 minutes
• 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
• Time from onset of persistent chest pain to randomization ≤12 hours
• Primary PCI expected to be performed ≥30 minutes, and ≤120 minutes

You may not qualify if…

• Cardiogenic shock
• 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)
• Ischemic stroke or TIA in the past 6 months
• History of hemorrhagic stroke
• Known intracranial aneurysm
• Severe trauma, surgery or head injury within 1 month
• Suspected aortic dissection or infective endocarditis
• Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture)
• Currently taking anticoagulants
• Poorly controlled hypertension ( ≥180/110 mmHg)
• 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)
• Known allergy to r-SAK
• Pregnancy, lactation, or planning for pregnancy
• History of chronic total occlusion, myocardial infarction or CABG
• Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset
• Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators

Where it is running

• Changzhou Second People's Hospital — Changzhou, China (enrolling)
• Changzhou Wujin People's Hospital — Changzhou, China (enrolling)
• The First People's Hospital of Changzhou — Changzhou, China (enrolling)
• Chongqing Hospital of Jiangsu Province Hospital — Chongqing, China (enrolling)
• The second Affiliated Hospital of Dalian Medical University — Dalian, China (enrolling)
• Daqing Oilfield General Hospital — Daqing, China (enrolling)
• Dongguan People's Hospital — Dongguan, China (enrolling)
• Fengcheng People's Hospital — Fengcheng, China (enrolling)
• General Hospital of Southern Theatre Command — Guangzhou, China (enrolling)
• The Second Affiliated Hospital of Hainan Medical University — Hainan, China (enrolling)
• The Affiliated Hospital of Hangzhou Normal University — Hangzhou, China (enrolling)
• The Second Affiliated Hospital of Zhejiang University Medical College — Hangzhou, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (enrolling)
• Huai'an First People's Hospital — Huai'an, China (enrolling)
• Huai'an Second People's Hospital — Huai'an, China (enrolling)
• Donghai Country People's Hospital — Lianyungang, China (enrolling)
• The First People's Hospital of Lianyungang — Lianyungang, China (enrolling)
• The Second People's Hospital of Lianyungang — Lianyungang, China (enrolling)
• Liyang Hospital of Jiangsu Province Hospital — Liyang, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (enrolling)
• Nanjing Tongren Hospital — Nanjing, China (enrolling)
• Sir Run Run Hospital Nanjing Medical University — Nanjing, China (enrolling)
• The Fourth Affiliated Hospital of Nanjing Medical University — Nanjing, China (enrolling)
• Nanjing Qixia District Hospital — Nanning, China (enrolling)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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