IMPROVE-STEMI: pPCI Plus Low-dose r-SK in STEMI

NCT07875179 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: r-SK-pRCT-001
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, prospective, pragmatic, randomized controlled trial (IMPROVE-STEMI) aiming to evaluate the efficacy and safety of intracoronary low-dose recombinant streptokinase combined with primary percutaneous coronary intervention (pPCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). A total of 3,300 patients will be enrolled, consisting of a core randomized study (300 patients, 1:1 ratio to pPCI + recombinant streptokinase vs. pPCI alone) and an extended observational study (3,000 patients receiving pPCI + recombinant streptokinase). The primary outcome measure is the coronary angiography-derived index of microcirculatory resistance (caIMR) immediately after the procedure. Secondary outcomes include the incidence of major adverse cardiovascular events (MACE) at 1 year, TIMI flow grade, corrected TIMI frame count (CTFC), and myocardial salvage index. The study duration is 24 months after the first patient enrollment, with follow-up visits scheduled at Day 5, Week 4, Week 12, Week 24, and Week 52.

Conditions

ST Elevation Myocardial Infarction (STEMI)

Keywords

STEMI; Primary PCI; Recombinant Streptokinase; Intracoronary Thrombolysis; Coronary Microvascular Dysfunction; caIMR; MACE; Pragmatic Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Coronary Angiography-derived Index of Microcirculatory Resistance (caIMR)

  Microcirculatory resistance index calculated from coronary angiography images immediately after PCI.

  Immediately after PCI

Secondary Outcomes (10)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  1 year after PCI

• Corrected TIMI Frame Count (CTFC)

  Immediately after PCI

• Coronary Angiography-derived Fractional Flow Reserve (caFFR)

  Immediately after PCI

• Proportion of patients with ST-segment resolution >50% and >70%

  1 hour after PCI

• Myocardial Infarct Size

  Day 5 ± 2 days after PCI

Study Arms (2)

Experimental: pPCI + r-SK

EXPERIMENTAL

Standard pPCI procedure combined with intracoronary low-dose recombinant streptokinase (300,000 IU dissolved in 5% glucose 5mL).

Drug: Recombinant Streptokinase

Control: pPCI only

NO INTERVENTION

Standard pPCI procedure only.

Interventions

Recombinant Streptokinase DRUG

Intracoronary administration of 300,000 IU recombinant streptokinase dissolved in 5% glucose 5mL, injected distal to, within, and proximal to the thrombus via a microcatheter or perforated balloon after guidewire crossing.

Experimental: pPCI + r-SK

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) according to the guidelines.
• Onset of STEMI symptoms within 12 hours.
• TIMI thrombus grade ≥ 2.
• Age 18 to 75 years, inclusive, gender (male or female).
• Written informed consent obtained from the patient or their legal representative.

You may not qualify if:

• Pregnant or breastfeeding women.
• Severe cardiovascular diseases, including cardiogenic shock, cardiac rupture, or acute aortic syndrome (e.g., aortic dissection, coronary artery dissection, or aneurysm) that cannot be excluded.
• Known coronary artery disease unsuitable for revascularization.
• Previously known severe heart disease.
• Patients with ventricular fibrillation requiring cardiopulmonary resuscitation or refractory to 3 electrical defibrillation attempts.
• Continuous oral anticoagulant use for ≥ 3 months.
• High risk of bleeding or other contraindications to thrombolytic therapy.
• Body weight \< 40 kg or \> 200 kg.
• Allergy to recombinant streptokinase or contrast agents.
• Other systemic diseases, including life expectancy \< 1 year due to other diseases, severe liver or kidney dysfunction, hematological diseases, acute pancreatitis, diabetic retinopathy, consciousness disorders, or malignant tumors.
• Any condition that the investigator considers unsuitable for participation in this study.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead
• China Association for Disaster & Emergency Rescue Medicine: collaborator
• Henan Singtier Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

Related Publications (2)

• Xiao Y, Fu X, Wang Y, Fan Y, Wu Y, Wang W, Zhang Q. Effects of different strategies on high thrombus burden in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary catheterization. Coron Artery Dis. 2019 Dec;30(8):555-563. doi: 10.1097/MCA.0000000000000743.

  PMID: 30998610 BACKGROUND

• Rehan R, Virk S, Wong CCY, Passam F, Layland J, Keech A, Yong A, White HD, Fearon W, Ng M. Intracoronary thrombolysis in ST-elevation myocardial infarction: a systematic review and meta-analysis. Heart. 2024 Jul 10;110(15):988-996. doi: 10.1136/heartjnl-2024-324078.

  PMID: 38925881 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yuan Lu, M.D.

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Lu, M.D.

CONTACT

+86 85805192; drluyuan329@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the nature of the interventional procedure and the administration of the study drug during PCI, neither the participants nor the care providers are masked to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study consists of two parts. The core study is a multicenter, prospective, open-label, pragmatic, randomized controlled trial (RCT) with two parallel arms (1:1 ratio): the experimental group (pPCI + intracoronary recombinant streptokinase) and the control group (pPCI alone). The extended study is a multicenter, prospective, open-label, observational study, in which all enrolled patients receive pPCI + intracoronary recombinant streptokinase. A single center cannot participate in both parts simultaneously.

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: October 15, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): September 28, 2028
• Study Completion (Estimated): September 28, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)