Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI (NOSLOWFLOW-Ⅰ)

Zhengzhou University

Status: Unknown

Conditions: ST Segment Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention

Treatments: Drug: Nitroprusside Sodium; Drug: Heparinized saline; Drug: Tirofiban Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03406819

KS-2017-176

Details and patient eligibility

About

Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic symptoms < 12h, or evidence of ongoing ischemia 12h after symptom onset
• Continued ischemic chest pain > 30min
• ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)
• Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)
• Primary coronary artery angiography was planned.

Exclusion criteria

• Emergency thrombolytic therapy was performed before primary coronary artery angiography
• Cardiogenic shock with no response to hypervolemic treatment or vasopressor
• Severe cardiomyopathy or valvular disease requiring intervention
• Coronary ectasia
• Severe heart failure
• Contraindication or allergy to antiplatelet drugs
• Contraindication or allergy to experimental drugs
• Unable to receive at least 1 year of dual antiplatelet therapy
• Active bleeding or extreme-risk for major bleeding
• Severe liver or renal failure
• Life expectancy < 1 year
• Unable or unwilling to provide informed consent
• Women of child bearing potential
• Under 18 years of age
• Hemoglobin < 90g/L
• Platelet count < 100×10^9/L
• Can not cooperate (with mental disorders or cognitive disorders)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 3 patient groups, including a placebo group

Nitroprusside group

Experimental group

Description:

After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation.

Treatment:

Drug: Nitroprusside Sodium

Tirofiban group

Experimental group

Description:

After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed.

Treatment:

Drug: Tirofiban Hydrochloride

Control group

Placebo Comparator group

Description:

After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed.

Treatment:

Drug: Heparinized saline