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Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis (TREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02298088
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:
Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis

Condition or disease Intervention/treatment Phase
Acute ST Segment Elevation Myocardial Infarction Thrombolysis in Myocardial Infarction Flow Drug: Ticagrelor 180 mg Drug: Clopidogrel Phase 3

Detailed Description:
Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated with Pharmacological Thrombolysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3799 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Blinded adjudication
Primary Purpose: Treatment
Official Title: Phase III, Randomized, International, Multicenter, Open Label, With Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With Acute Coronary Syndrome With ST Elevation Treated With Pharmacological Thrombolysis.
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Ticagrelor 180 mg
Patients assigned to Ticagrelor will receive oral Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.
Drug: Ticagrelor 180 mg
Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.
Other Name: Ticagrelor

Active Comparator: Clopidogrel

Patients will take the 300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months.

For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.

Drug: Clopidogrel

300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months.

For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.





Primary Outcome Measures :
  1. Safety Outcome as a measure of Time to TIMI-defined first major bleeding [ Time Frame: 30 days ]

    The primary safety endpoint is time to TIMI-defined and adjudicated first major bleeding event (including major life-threatening bleeding and other major bleeding).

    Bleeding TIMI Definition

    Major:

    Any intracranial hemorrhage (ICH)*, OR Clinically significant overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of ≥ 5 g/dL (or, when Hgb is not available, an absolute drop in hematocrit (Hct) of ≥ 15%).

    An independent blinded central adjudication committee will adjudicate all suspected primary end points.



Secondary Outcome Measures :
  1. Efficacy Outcome as a measure of major cardiovascular events [ Time Frame: 12 months ]

    Secondary efficacy combined endpoint: death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, recurrent ischemia, TIA, or other arterial thrombotic event.

    We will also measure the individual outcomes all-cause mortality and need for rescue PCI, as well as individual components of the combined efficacy endpoint.


  2. Safety Outcome as a measure of bleeding event [ Time Frame: 12 months ]
    Secondary safety endpoints: Total bleeding (major and minor) according to PLATO, TIMI and BARC definitions, minor bleeding according to the TIMI definition and major bleeding as individual endpoint according to the PLATO definition. Others safety variables will include: dyspnea, arrhythmia, bradycardia and laboratory safety tests



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes aged ≥ 18 years and < 75 years with ACS with ST segment elevation with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of > 10 minutes duration at rest, treated with pharmacological thrombolysis
  • Fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours

Patients with acute coronary syndrome with ST segment elevation will be included provided they present ST segment elevation at the J point in two contiguous leads in electrocardiogram with cut-points: > 0.1mV in all leads other than leads V2-V3, where the following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or >0.15 mV in women and at least 1 of the following criteria:

  • Angina-like chest pain or ischemic equivalent chest pain;
  • Abnormalities above the reference value for markers of myocardial necrosis (troponin and CK-MB).

The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.

Exclusion Criteria:

  • Any contraindication against the use of clopidogrel (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, history of intracranial hemorrhage)
  • Need for oral anticoagulation therapy,
  • Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine)
  • Increased risk of bradycardia events
  • Dialysis required
  • Known clinically important thrombocytopenia
  • Known clinically important anemia
  • Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer)
  • Participant in another investigational drug or device study within 30 d
  • Pregnancy or lactation
  • Any condition that increases the risk for noncompliance or being lost to follow-up
  • Involvement in the planning or conduct of the study
  • Previous enrollment or randomization in this study
  • Contraindications to fibrinolytic therapy including: 15

    • Any prior intracranial hemorrhage
    • Known structural cerebral vascular lesion (eg, Arterial Venous Malformation - AVM)
    • Known malignant intracranial neoplasm (primary or metastatic)
    • Ischemic stroke within 3 months
    • Suspected aortic dissection
    • Active bleeding or bleeding diathesis (excluding menses)
    • Significant closed head trauma or facial trauma within 3 months

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): NCT02298088


Locations
Show Show 153 study locations
Sponsors and Collaborators
Hospital do Coracao
Investigators
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Study Chair: Otavio Berwanger, MD,PhD Hospital do Coracao
Study Chair: Helio P Guimaraes, MD,PhD Hospital do Coracao
Study Chair: Leopoldo S Piegas, MD,PhD Hospital do Coracao
Study Chair: Renato D Lopes, MD,PhD Duke University
Study Chair: Jose C Nicolau, MD,PhD Instituto do Coracao HC-FMUSP
Study Chair: Francisco A Fonseca, MD,PhD Universidade Federal de São Paulo
Study Chair: Jose F Saraiva, MD,PhD Hospital e Maternidade Celso Pierro
Study Chair: Carlos Tajer, MD,PhD Investigación Independiente S.A.
Study Chair: Stephen Nicholls, MD,PhD South Australian Health and Medical Research Institute
Study Chair: Shaun Goodman, MD,PhD Canadian Heart Research Centre
Study Chair: Lixin Jiang, MD,PhD Fuwai Hospital
Study Chair: Harvey White, MD,PhD Auckland City Hospital - Auckland District Health Board
Study Chair: Germán Malaga, MD,PhD Universidad Peruana Cayetano Heredia
Study Chair: Oleg Averkov, MD,PhD Clinical Hospital #15 Clinical Hospital #15 named after O.M.Filatov, Moscow, Russia
Study Chair: Alexander Parkhomenko, MD,PhD Institute of Cardiology - Emergency Cardiology Department
Study Chair: Christopher Granger, MD,PhD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT02298088    
Other Study ID Numbers: TREAT01
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs