NCT07875179Not yet recruitingPhase 4
IMPROVE-STEMI: pPCI Plus Low-dose r-SK in STEMI
Impact of Intra-procedural pPCI Combined With Low-dose Recombinant Streptokinase on Coronary MicroVascular Dysfunction and Events in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Multicenter, Prospective, Pragmatic, Randomized Controlled Trial Protocol
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 3300 (estimated)
- First submitted
- 20 Sept 2026
- Start date
- 28 Sept 2026
- Primary completion date
- 28 Sept 2028
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT07875179
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 3300
- From 28 Sept 2026 to the primary completion date, 28 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously known severe heart disease.
Other illness
- 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.
- High risk of bleeding or other contraindications to thrombolytic therapy.
- 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.
Other
- Pregnant or breastfeeding women.
- Patients with ventricular fibrillation requiring cardiopulmonary resuscitation or refractory to 3 electrical defibrillation attempts.
- Continuous oral anticoagulant use for ≥ 3 months.
- Body weight \< 40 kg or \> 200 kg.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.