---
title: "Intracoronary prourokinase for slow‑flow/no‑reflow during PCI in ACS: randomized double‑blind tria"
id: "bmj-open-5-efficacy-and-safety-of-intracoronary-injection-of-recombinant-human"
canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-5-efficacy-and-safety-of-intracoronary-injection-of-recombinant-human"
content_type: "clinical_feed_article"
specialty: "Cardiology"
source_name: "BMJ Open"
source_url: "http://bmjopen.bmj.com/cgi/content/short/16/8/e115027?rss=1"
published_at: "2026-08-11T10:40:53.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Intracoronary prourokinase for slow‑flow/no‑reflow during PCI in ACS: randomized double‑blind tria
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-5-efficacy-and-safety-of-intracoronary-injection-of-recombinant-human
- **Specialty:** [Cardiology](https://medichelpline.com/clinical-feed/cardiology.md)
- **Primary Source:** BMJ Open
- **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/8/e115027?rss=1)
- **Published At:** 2026-08-11T10:40:53.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The coronary **slow‑flow/no‑reflow** phenomenon after percutaneous coronary intervention (**PCI**) in acute coronary syndrome (**ACS**) is linked to worse outcomes, including higher cardiovascular mortality and heart failure incidence. - Existing therapies lack robust guideline support and are not backed by large-scale randomized evidence. - **Prourokinase**, a fibrin‑specific recombinant human thrombolytic, may improve microvascular perfusion via targeted fibrinolysis when delivered intracoronarily. - Current evidence for intracoronary prourokinase is limited to small studies; a larger randomized trial is needed to evaluate clinical benefit and safety. - This study is a national, multicentre, randomized, double‑blind, placebo‑controlled protocol testing low‑dose intracoronary prourokinase delivered by microcatheter in the infarct‑related artery during PCI for ACS patients who develop slow‑flow/no‑reflow. - All participants receive standard intensive antiplatelet therapy, nitrates and calcium channel blockers in addition to the randomized study agent or placebo. - The primary outcome is 12‑month incidence of **major adverse cardiovascular events (MACE)**, a composite of cardiovascular death, recurrent myocardial infarction, hospitalisation for unstable angina, unplanned repeat revascularisation, hospitalisation for heart failure, or non‑fatal stroke. - Secondary outcomes assess myocardial reperfusion (TIMI flow grade, TIMI frame count), infarct severity (ST‑segment resolution, troponin T area under the curve), angina severity (CCS class), cardiac function (LVEF, NYHA class) and short‑term MACE. - Safety focus includes the incidence of major bleeding events; the trial aims to determine whether prourokinase reduces MACE without increasing major bleeding. - The protocol follows the Declaration of Helsinki and has ethics approval from Sun Yat‑sen Memorial Hospital (Approval No: SYSKY‑2024‑735‑04). Trial registration: ChiCTR2500103336. - Planned dissemination includes peer‑reviewed journals, international conferences, stakeholder outreach and digital platforms to support translation into practice.
## Clinical Analysis & Structured Key Points
Introduction The coronary slow-flow/no-reflow phenomenon adversely affects clinical outcomes following percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS), demonstrating a substantial association with increased cardiovascular mortality and heart failure incidence. Despite its significant clinical implications, current therapeutic strategies for this condition lack robust guideline recommendations and are not supported by large-scale clinical evidence. Intracoronary administration of recombinant human prourokinase, a novel fibrin-specific thrombolytic, demonstrates potential for improving microvascular dysfunction through targeted fibrinolysis. Nevertheless, current evidence is limited to small-scale clinical studies, lacking large-scale trials to guideline recommendations. This study aims to investigate whether selective intracoronary administration of prourokinase, in addition to conventional intensive antiplatelet therapy, nitrates and calcium channel blockers, can reduce the incidence of cardiovascular events at 12 months post-PCI in patients with ACS experiencing slow flow/no-reflow during the procedure without increasing the incidence of major bleeding events. Methods and analysis This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy of low-dose intracoronary administration of prourokinase or placebo via a microcatheter in the infarct-related artery in patients with ACS with slow flow/no-reflow during PCI. The primary endpoint is the incidence of major adverse cardiovascular events (MACE) 12 months after the intervention, defined as the composite of cardiovascular death, recurrent myocardial infarction, hospitalisation for unstable angina, unplanned repeat revascularisation, hospitalisation for heart failure or non-fatal stroke, whichever occurs first. Secondary endpoints include myocardial reperfusion (thrombolysis in myocardial infarction (TIMI) flow grade, TIMI frame count), myocardial infarction severity (ST-segment resolution, infarct area estimated from area under the curve of cardiac troponin T), angina severity (Canadian Cardiovascular Society grading of angina pectoris), cardiac function (left ventricular ejection fraction, New York Heart Association functional classification) and short-term MACE. Ethics and dissemination Ethics This study will adhere to the principles outlined in the Declaration of Helsinki and other applicable ethical guidelines. The study protocol has been approved by the Medical Research Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University (Approval No: SYSKY-2024-735-04). Dissemination We will disseminate findings via peer-reviewed journals, international conferences and stakeholder outreach (clinicians, policymakers and patients), supplemented by digital platforms to accelerate knowledge translation and clinical implementation. Trial registration number ChiCTR2500103336.
## Related Clinical Research

- [Semaglutide and Primary Prevention of MACCE in Obese Adults with T2DM and Rheumatoid Arthritis](https://medichelpline.com/clinical-feed/pubmed-42334436.md) (DOI: 10.1093/ehjcvp/pvag044)
- [Neural-Immune-Cardiovascular Axis: Mechanisms and Therapeutic Targets in Cardiovascular Disease](https://medichelpline.com/clinical-feed/frontiers-in-immunology-13-neural-immune-cardiovascular-axis-from-mechanistic-crosstalk-to-therapeutic.md)
- [Optimal DAPT Duration After PCI with Contemporary DES: Network Meta-analysis of RCTs](https://medichelpline.com/clinical-feed/plos-one-7-dual-antiplatelet-therapy-duration-after-percutaneous-coronary-intervention.md)
- [Stepwise DAPT de-escalation vs standard DAPT after drug-coated balloon angioplasty in multivessel](https://medichelpline.com/clinical-feed/medrxiv-15-impact-of-stepwise-dual-antiplatelet-therapy-de-escalation-in-patients-with.md)
- [Accuracy of EMR Retrieval Methods and a Large Language Model for Identifying Cardiovascular Events](https://medichelpline.com/clinical-feed/bmj-open-6-diagnostic-accuracy-of-electronic-medical-record-retrieval-methods-and-a-large.md)

## Navigation
- [← Back to Cardiology Feed](https://medichelpline.com/clinical-feed/cardiology.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.