Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.

Shanghai Zhongshan Hospital500 enrolled

Overview

Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

ST Elevation Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours; * ST segment elevated ≥ 0.1mV in adjacent two or more leads; * Scheduled for primary percutaneous coronary intervention without contraindications; * Written informed consent is obtained. Exclusion Criteria: * Life expectancy ≤ 1 year; * History of cerebral hemorrhage; * History of stroke in 6 months; * Active hemorrhage; * Severe hepatic and renal dysfunction(ALT \> 3 folds of upper limit of normal, eGFR \< 30ml/min/1.73mm\^2 or Scr \> 200 mmol/L); * Known hemorrhagic diseases; * Known malignant tumour diseases； * Active peptic ulcer disease; * Blood platelet counts \< 100×10\^9/L; * Blood hemoglobin \< 90g/L; * Pregnancy or lactation period； * Take part in other intervention clinical trials； * Investigators think not suitable to participate in this trial.

Outcomes

Primary Outcomes

TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).

TIMI flow grades: grade III.

Time frame: Immediately after primary percutaneous coronary intervention.

TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).

TIMI myocardial perfusion grades: grade III.

Time frame: Immediately after primary percutaneous coronary intervention.

Secondary Outcomes

Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.

Remedial Tirofiban use during primary percutaneous coronary intervention.

Time frame: During the process of primary percutaneous coronary intervention.

ST segment

The sum of the initial ST segment elevation drops 70% or more.

Time frame: 90 minutes after primary percutaneous coronary intervention.

Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).

Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging.

Time frame: 7 days after primary percutaneous coronary intervention.

Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.

Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.

Time frame: 30 days after primary percutaneous coronary intervention.