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

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ClinicalTrials.gov Identifier: NCT03797729
Recruitment Status : Not yet recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: Tirofiban Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Normal saline Drug: 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 Name: Sodium Chloride Injection

Experimental: Tirofiban Drug: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. ST segment [ Time Frame: 90 minutes after primary percutaneous coronary intervention. ]
    The sum of the initial ST segment elevation drops 70% or more.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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)

  4. 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).

  5. 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.


  6. 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

  7. Adverse events and severe adverse events. [ Time Frame: 30 days after primary percutaneous coronary intervention. ]
    Adverse events and severe adverse events.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797729


Contacts
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Contact: Zhangwei Chen, MD +8602164041990 ext 612747 chen.zhangwei@zs-hospital.sh.cn
Contact: Hongyi Wu, MD +8602164041990 wu.hongyi@zs-hospital.sh.cn

Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Juying Qian, MD Fudan University

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03797729     History of Changes
Other Study ID Numbers: TRYIT
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Shanghai Zhongshan Hospital:
ST Elevation Myocardial Infarction
Tirofiban
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors