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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tirofiban
Normal saline
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST Elevation Myocardial Infarction, Tirofiban, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Normal saline

Tirofiban

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.
Remedial Tirofiban use during primary percutaneous coronary intervention.
ST segment
The sum of the initial ST segment elevation drops 70% or more.
Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).
Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging.
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.

Full Information

First Posted
January 1, 2019
Last Updated
January 20, 2020
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03797729
Brief Title
Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.
Official Title
Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
ST Elevation Myocardial Infarction, Tirofiban, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Title
Tirofiban
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Sodium Chloride Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
Description
TIMI flow grades: grade III.
Time Frame
Immediately after primary percutaneous coronary intervention.
Title
TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
Description
TIMI myocardial perfusion grades: grade III.
Time Frame
Immediately after primary percutaneous coronary intervention.
Secondary Outcome Measure Information:
Title
Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.
Description
Remedial Tirofiban use during primary percutaneous coronary intervention.
Time Frame
During the process of primary percutaneous coronary intervention.
Title
ST segment
Description
The sum of the initial ST segment elevation drops 70% or more.
Time Frame
90 minutes after primary percutaneous coronary intervention.
Title
Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).
Description
Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging.
Time Frame
7 days after primary percutaneous coronary intervention.
Title
Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
Description
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.
Other Pre-specified Outcome Measures:
Title
Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.
Description
Left ventricular ejection fraction assessed by transthoracic echocardiography.
Time Frame
7 and 30 days after primary percutaneous coronary intervention.
Title
The serum microRNA expression pattern changes after primary percutaneous coronary intervention.
Description
The microRNA expression pattern changes.
Time Frame
Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention.
Title
All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)
Description
All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)
Time Frame
30 days after primary percutaneous coronary intervention.
Title
Major bleeding events assessed by TIMI bleeding criteria.
Description
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).
Time Frame
30 days after primary percutaneous coronary intervention.
Title
Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria.
Description
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.
Time Frame
30 days after primary percutaneous coronary intervention.
Title
Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria.
Description
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
Time Frame
30 days after primary percutaneous coronary intervention.
Title
Adverse events and severe adverse events.
Description
Adverse events and severe adverse events.
Time Frame
30 days after primary percutaneous coronary intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangwei Chen, MD
Phone
+8602164041990
Ext
612747
Email
chen.zhangwei@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongyi Wu, MD
Phone
+8602164041990
Email
wu.hongyi@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juying Qian, MD
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhangwei Chen, MD
Phone
+86 21 64041990
Email
chen.zhangwei@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Danbo Lu, PhD
Phone
+86 21 64041990
Email
lu.danbo@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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