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

January 20, 2020 updated by: Shanghai Zhongshan Hospital

Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.

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 Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Normal saline
Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.
Other Names:
  • Sodium Chloride Injection
EXPERIMENTAL: Tirofiban
Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.
Time Frame: During the process of primary percutaneous coronary intervention.
Remedial Tirofiban use during primary percutaneous coronary intervention.
During the process of primary percutaneous coronary intervention.
ST segment
Time Frame: 90 minutes after primary percutaneous coronary intervention.
The sum of the initial ST segment elevation drops 70% or more.
90 minutes after primary percutaneous coronary intervention.
Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).
Time Frame: 7 days after primary percutaneous coronary intervention.
Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging.
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.
Time Frame: 30 days after primary percutaneous coronary intervention.
Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
30 days after primary percutaneous coronary intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.
Time Frame: 7 and 30 days after primary percutaneous coronary intervention.
Left ventricular ejection fraction assessed by transthoracic echocardiography.
7 and 30 days after primary percutaneous coronary intervention.
The serum microRNA expression pattern changes after primary percutaneous coronary intervention.
Time Frame: Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention.
The microRNA expression pattern changes.
Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention.
All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)
Time Frame: 30 days after primary percutaneous coronary intervention.
All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)
30 days after primary percutaneous coronary intervention.
Major bleeding events assessed by TIMI bleeding criteria.
Time Frame: 30 days after primary percutaneous coronary intervention.
Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI); Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥ 5 g/dL; Fatal bleeding (bleeding that directly results in death within 7 d).
30 days after primary percutaneous coronary intervention.
Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria.
Time Frame: 30 days after primary percutaneous coronary intervention.

GUSTO bleeding criteria:Severe or life-threatening :

Intracerebral hemorrhage ; Resulting in substantial hemodynamic compromise requiring treatment.

Moderate:

Requiring blood transfusion but not resulting in hemodynamic compromise.

Mild :

Bleeding that does not meet above criteria.

30 days after primary percutaneous coronary intervention.
Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria.
Time Frame: 30 days after primary percutaneous coronary intervention.
Fatal bleeding and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing hemoglobin drop of 20 g/L or more, and/or blood transfusion of 2 units or more
30 days after primary percutaneous coronary intervention.
Adverse events and severe adverse events.
Time Frame: 30 days after primary percutaneous coronary intervention.
Adverse events and severe adverse events.
30 days after primary percutaneous coronary intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Juying Qian, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2019

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 1, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (ACTUAL)

January 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 20, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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