Non-stenting approach for acute heart attack with non-severe narrowing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open-label, non-inferiority randomized trial enrolling about 2,000 patients with STEMI or NSTEMI within 24 hours to 14 days of onset. All participants must have residual culprit-lesion stenosis under 70% and TIMI 3 flow after angiography, and a vessel diameter between 2.5 and 4.0 mm. Participants are randomized 1:1 to receive guideline-directed medical therapy alone or DES implantation plus therapy and will be followed for at least 12 months, with an overall goal of longer follow-up until study end. The primary outcome is time to first cardiovascular death, target-vessel MI, or ischemia-driven target-lesion revascularization. The study seeks to determine if medical therapy alone is non-inferior to DES in preventing major adverse cardiovascular events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged ≥18 years and ≤75 years;
2. Diagnosis of type 1 AMI, including STEMI (onset \<24 hours or 7-14 days) or NSTEMI;
3. After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) \<70% at the culprit lesion (QCA);
4. Reference diameter of the culprit lesion \>2.5 mm and ≤4.0 mm;
5. Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

1.Clinical exclusion criteria:

1. Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF \< 30%;
2. Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
3. Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
4. Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
5. Contraindication to contrast;
6. Severe renal dysfunction \[defined as eGFR ≤30 ml/min/1.73m² or Scr ≥2.0 mg/dL\] without regular dialysis (patients with chronic renal insufficiency on regular dialysis may be considered for enrollment);
7. Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST \>3× upper limit of normal (ULN);
8. Previous history of CABG or PCI for the culprit lesion;
9. Patients with other concurrent severe diseases and an expected life expectancy of \<1 year;
10. Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
11. Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.

2.Imaging exclusion criteria:

1. Non-culprit lesion with DS ≥70% or planned revascularization;
2. Left main coronary artery lesion with DS ≥50%;
3. Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;
4. Long lesion (planned stent length \>60 mm);
5. Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;
6. Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.).

3.Functional sub study:

1. Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;
2. Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);
3. Patients with bronchial asthma.

Where it's running

• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• Beijing Luhe Hospital Affiliated to Capital Medical University
  Beijing, China Not yet recruiting
• Fuwai Hospital, Chinese Academy of Medical Sciences
  Beijing, China Not yet recruiting
• Cangzhou Central Hospital
  Cangzhou, China Not yet recruiting
• Chengde Medical College Affiliated Hospital
  Chengde, China Not yet recruiting
• Sichuan Provincial People's Hospital
  Chengdu, China Not yet recruiting

Study contacts

• Principal investigator: Bo Yu, Ph.D. — The Second Affiliated Hospital of Harbin Medical University
• Study coordinator: Jingbo Hou, Ph.D.
• Email: jingbohou@163.com
• Phone: 13303609625

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.