Trial | NCT03406819  Report issue

Title

Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI
Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    1000
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.
Study Started
Jan 07
2018
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Jan 23
2018

Drug Nitroprusside Sodium

Intracoronary infusion 50~100μg each time (repeated)

  • Other names: Experimental-1 group

Drug Tirofiban Hydrochloride

Intracoronary infusion 10μg/kg for single time

  • Other names: Experimental-2 group

Drug Heparinized saline [heparin (liquaemin), sodium chloride]

Intracoronary infusion 2ml for single time

  • Other names: Control group

Nitroprusside group Experimental

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.

Tirofiban group Experimental

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.

Control group Placebo Comparator

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.

Criteria 

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)
No Results Posted